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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04993443




Registration number
NCT04993443
Ethics application status
Date submitted
17/05/2021
Date registered
6/08/2021
Date last updated
5/09/2021

Titles & IDs
Public title
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
Scientific title
A Single and Multiple-dose Escalation First-in-Human Study Evaluating the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Administered Via Inhalation and IV Infusion in Healthy Subjects
Secondary ID [1] 0 0
LQ036A001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LQ036
Other interventions - Matching Placebo

Experimental: Active Comparator: Drug :LQ036 - Experimental, Single and Multiple Oral escalating dose

Placebo Comparator: Placebo Comparator: Matching Placebo for LQ036 - Matching Placebo for LQ036: Matching Placebo


Treatment: Drugs: LQ036
For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects initiating dosing no sooner than the next day. Cohorts will be dosed sequentially in an ascending fashion. Each study part (A, B and C) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4.

Other interventions: Matching Placebo
Matching Placebo for LQ036: Matching Placebo

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of outcome of Adverse events
Timepoint [1] 0 0
Up to 5 weeks.
Primary outcome [2] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Abnormal blood pressure
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
Timepoint [2] 0 0
Up to 1 Month
Primary outcome [3] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Abnormal pulse rate
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
Timepoint [3] 0 0
Up to 1 Month
Primary outcome [4] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Abnormal respiratory rate
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
Timepoint [4] 0 0
Up to 1 Month
Primary outcome [5] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Abnormal Tympanic Temperature
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.
Timepoint [5] 0 0
Up to 1 Month
Primary outcome [6] 0 0
To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables. - Change in electrocardiograms (ECGs).
Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 8, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.
Part B: At check-in (Day -1), and pre-dose and 1, 2, and 8 hours post-dose on Days 1 to 12, and at discharge (Day 13), and on Days 15±1, 22±1, and 29±1.
Timepoint [6] 0 0
Up to 1 Month
Primary outcome [7] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (hemoglobin)
Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
Timepoint [7] 0 0
Up to 5 Weeks
Primary outcome [8] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (hematocrit)
Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
Timepoint [8] 0 0
Up to 5 Weeks
Primary outcome [9] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (mean corpuscular volume)
Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
Timepoint [9] 0 0
Up to 5 Weeks
Primary outcome [10] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (leukocyte counts)
Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
Timepoint [10] 0 0
Up to 5 Weeks
Primary outcome [11] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (platelet count)
Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
Timepoint [11] 0 0
Up to 5 Weeks
Primary outcome [12] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (Urea)
Part B: At check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).
Timepoint [12] 0 0
Up to 5 Weeks
Primary outcome [13] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (creatinine)
Timepoint [13] 0 0
Up to 5 Weeks
Primary outcome [14] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (alkaline phosphatase)
Timepoint [14] 0 0
Up to 5 Weeks
Primary outcome [15] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (glucose)
Timepoint [15] 0 0
Up to 5 Weeks
Primary outcome [16] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (alanine aminotransferase (ALT))
Timepoint [16] 0 0
Up to 5 Weeks
Primary outcome [17] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (aspartate amino transferase (AST))
Timepoint [17] 0 0
Up to 5 Weeks
Primary outcome [18] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (total bilirubin)
Timepoint [18] 0 0
Up to 5 Weeks
Primary outcome [19] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (sodium)
Timepoint [19] 0 0
Up to 5 Weeks
Primary outcome [20] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (potassium)
Timepoint [20] 0 0
Up to 5 Weeks
Primary outcome [21] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (chloride)
Timepoint [21] 0 0
Up to 5 Weeks
Primary outcome [22] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (calcium)
Timepoint [22] 0 0
Up to 5 Weeks
Primary outcome [23] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (total proteins)
Timepoint [23] 0 0
Up to 5 Weeks
Primary outcome [24] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (Phosphorus)
Timepoint [24] 0 0
Up to 5 Weeks
Primary outcome [25] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (albumin)
Timepoint [25] 0 0
Up to 5 Weeks
Primary outcome [26] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (Coagulation test (aPTT (Activated partial thromboplastin time) and INR (International Normalized Ratio))
Part B: At screening and at study exit (Day 36±1)
Part A and C: At screening and at study exit (Day 29±1).
Timepoint [26] 0 0
Up to 5 Weeks
Primary outcome [27] 0 0
To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Assessment of abnormal clinical laboratory tests (Urine macroscopic examination, pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, nitrite, urobilinogen, and leukocytes)
Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).
Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), and at study exit (Day 29±1).
Timepoint [27] 0 0
Up to 5 Weeks
Primary outcome [28] 0 0
To evaluate the tolerability of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Local tolerability (oropharyngeal) assessment (Part A) and (injection site) assessment (Part C): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness.
Time frame: pre-dose, Day 1, 2, 4, 8, and 24 hours post-dose, and at Day 3.
Local tolerability (oropharyngeal) assessment (Part B): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness.
Time frame: pre-dose (as well as 1, 2, and 4 hours post-dose on Days 1, 3, 5, 8, and 10, 11, and at Day 13.
Timepoint [28] 0 0
Up to two weeks
Primary outcome [29] 0 0
To evaluate the immunogenicity of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Immunogenicity data that will be evaluated include Anti-Drug Antibody test sampling (ADA).
Parts A and C: A total of 5 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, and 22±1, and at study exit (Day 29±1)
Part B: A total of 6 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, 22±1, 29±1, and at study exit (Day 36±1)
Timepoint [29] 0 0
Up to 3 Weeks
Primary outcome [30] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - AUC0-t: Area under the concentration-time curve from time zero until the last observed concentration
Timepoint [30] 0 0
Up to 2 Weeks
Primary outcome [31] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)
Timepoint [31] 0 0
Up to 2 Weeks
Primary outcome [32] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100
Timepoint [32] 0 0
Up to 2 Weeks
Primary outcome [33] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - AUC0-24: Area under the concentration-time curve from time zero to 24 hours post-dose.
Timepoint [33] 0 0
Up to 2 Weeks
Primary outcome [34] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - AUC0-t: Area under the concentration-time curve for one dosing interval (t) at steady-state. In this study t = 24 hours (AUC0-24)
Timepoint [34] 0 0
Up to 2 Weeks
Primary outcome [35] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - AUC0-72: Area under the concentration-time curve from time zero to 72 hours post-dose.
Timepoint [35] 0 0
Up to 2 Weeks
Primary outcome [36] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Cmax: Maximal observed concentration
Timepoint [36] 0 0
Up to 2 Weeks
Primary outcome [37] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Cmax ss: maximum observed concentration at steady-state
Timepoint [37] 0 0
Up to 2 Weeks
Primary outcome [38] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Cmin ss: minimum observed concentration at steady-state
Timepoint [38] 0 0
Up to 2 Weeks
Primary outcome [39] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Tmax ss: time of observed Cmax at steady-state
Timepoint [39] 0 0
Up to 2 Weeks
Primary outcome [40] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Tmax: Time of Cmax
Timepoint [40] 0 0
Up to 2 Weeks
Primary outcome [41] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - T½ el: Terminal elimination half-life
Timepoint [41] 0 0
Up to 2 Weeks
Primary outcome [42] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (Kel) - Kel: Terminal elimination rate constant
Timepoint [42] 0 0
Up to 2 Weeks
Primary outcome [43] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (Racc) - Racc: drug accumulation ratio
Timepoint [43] 0 0
Up to 2 Weeks
Primary outcome [44] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (PTF%) - PTF%: peak trough fluctuation
Timepoint [44] 0 0
Up to 2 Weeks
Primary outcome [45] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Cl/F: Apparent body clearance, calculated as Dose / AUC0-inf
Timepoint [45] 0 0
Up to 2 Weeks
Primary outcome [46] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Vd/F: apparent volume of distribution, calculated as Dose / Kel * AUC0-inf
Timepoint [46] 0 0
Up to 2 Weeks
Primary outcome [47] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Clss/F: apparent body clearance at steady-state, calculated as dose / AUC0-inf
Timepoint [47] 0 0
Up to 2 Weeks
Primary outcome [48] 0 0
To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects - Vdss/F: apparent volume of distribution at steady-state, calculated as dose / (Kel * AUC0-inf)
Timepoint [48] 0 0
Up to 2 Weeks
Secondary outcome [1] 0 0
To compare the PK of LQ036 after administration via inhalation and IV routes - Serum levels of LQ036 will be quantified for PK analysis by a validated enzyme linked immunosorbent assay (ELISA) method.
Timepoint [1] 0 0
Up to 2 weeks
Secondary outcome [2] 0 0
To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (AUC0-24 versus AUC0-t) - Comparisons between Day 1 and Day 10 PK parameters: AUC0-24 versus AUC0-t will be done by Analysis of variance (ANOVA)
Timepoint [2] 0 0
Up to 2 weeks
Secondary outcome [3] 0 0
To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Cmax versus Cmax ss) - Comparisons between Day 1 and Day 10 PK parameters: Cmax versus Cmax ss will be done by Analysis of variance (ANOVA)
Timepoint [3] 0 0
Up to 2 weeks
Secondary outcome [4] 0 0
To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Tmax versus Tmax ss) - Comparisons between Day 1 and Day 10 PK parameters: Tmax versus Tmax ss will be done by Analysis of variance (ANOVA)
Timepoint [4] 0 0
Up to 2 weeks

Eligibility
Key inclusion criteria
- Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to
dosing.

2. the absence of a clinically significant history of neurological, endocrine,
cardiovascular, respiratory (except resolved childhood asthma), hematological,
immunological, psychiatric (except including depression that has not required
treatment for at least 6 months), gastrointestinal, renal, hepatic, and metabolic
disease.

- Females of childbearing potential who are sexually active with a male partner must be
willing to use one of the following acceptable contraceptive methods throughout the
study and for 30 days after the last study drug administration:

1. Simultaneous use of intrauterine device placed at least 4 weeks prior to study
drug administration, and condom for the male partner;

2. Simultaneous use of hormonal contraceptives started at least 4 weeks prior to
study drug administration and condom for the male partner.

3. Sterile male partner (vasectomized since at least 6 months).

- Male subjects who are not vasectomized for at least 6 months, and who are sexually
active with a female partner of childbearing potential (childbearing potential females
are defined as women that are neither post-menopausal nor surgically sterile) must be
willing to use one of the following acceptable contraceptive methods from the first
study drug administration until at least 90 days after the last study drug
administration:

1. Simultaneous use of a male condom and, for the female partner, hormonal
contraceptives used since at least 4 weeks, or intra-uterine contraceptive device
placed since at least 4 weeks;

2. Male subjects must be willing not to donate sperm until 90 days following the
last study drug administration.

- Subjects with normal lung function defined as greater than or equal to 80% predicted
forced expiratory volume in one second (FEV1).

- Capable of consent
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any clinically significant abnormality at physical examination, clinically significant
abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C
found during medical screening.

- Any clinically significant illness, infection, medical/surgical procedure, or trauma
within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the
study period.

- Any history of malignancy or neoplastic disease (not including excised, non-recurrent,
non-melanoma skin cancers).

- Positive urine drug screen, urine cotinine test, or alcohol breath test at screening.

- History of allergic reactions to LQ036, to any biologic therapy, or other related
drugs, or to any excipient in the formulation.

- Positive pregnancy test at screening.

- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood
pressure less than 90 or greater than 140 mmHg, diastolic blood pressure less than 50
or greater than 90 mmHg, or heart rate less than 50 or greater than 100 bpm) at
screening.

- History of significant alcohol abuse within 1 year prior to screening or regular use
of alcohol within 6 months prior to the screening visit. Regular use of alcohol is
defined as greater than 10 units of alcohol per week, where 1 unit is defined as 100
mL of wine at 13.5% a/v, 375 mL of beer at 3.5% a/v, or 30 mL of spirit at 40% a/v.

- History of significant drug abuse within 1 year prior to screening or use of soft
drugs (such as tetrahydrocannabinol) within 1 month prior to the screening visit or
hard drugs (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines,
cocaine, opiates, methylenedioxymethamphetamine, and phencyclidine) within 1 year
prior to screening.

- Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days prior to the first dosing,
administration of a biological product in the context of a clinical research study
within 90 days prior to the first dosing, or concomitant participation in an
investigational study involving no drug or device administration.

- Use of medications for the timeframes specified below, with the exception of
medications exempted by the Investigator on a case-by-case basis because they are
judged unlikely to affect the PK profile of the study drug or subject safety (e.g.,
topical drug products without significant systemic absorption):

1. Prescription medications (except for hormonal contraceptives) within 14 days
prior to the first dosing;

2. Over-the-counter products and natural health products (including herbal remedies,
homeopathic and traditional medicines, probiotics, food supplements such as
vitamins, minerals, amino acids, essential fatty acids, and protein supplements
used in sports) within 7 days prior to the first dosing, with the exception of
the occasional use of paracetamol/acetaminophen (up to 2 g daily), ibuprofen (up
to 800 mg daily), and oral contraceptives;

3. Depot injection or implant (except for hormonal contraceptives) of any drug
within 3 months prior to the first dosing;

4. Long-acting ß2 agonists for 4 weeks prior to screening;

5. Anti-immunoglobulin E,anti-Interleukin-5, or anti-Interleukin-4 Receptor therapy
for 6 months prior to screening;

6. Inhaled corticosteroids (greater than 500 µg/day of beclometasone dipropionate or
equivalent) within 16 weeks prior to screening, and none for 4 weeks prior to
screening;

7. Oral or injectable steroids for the treatment of asthma or respiratory tract
infection within 5 years prior to screening;

8. Intranasal steroids within 4 weeks prior to screening;

9. Topical steroids within 4 weeks prior to screening;

10. Leukotriene antagonists within 2 weeks prior to screening;

11. Anticholinergics or cromoglycate within 1 week prior to screening.

- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than
499 mL within 56 days prior to the first dosing.

- Breast-feeding subject.

- History of latent or active tuberculosis, or exposure to endemic areas within 8 weeks
prior to QuantiFERON®-TB testing performed at screening.

- Positive QuantiFERON®-TB test indicating possible tuberculosis infection.

- Immunization with a live attenuated vaccine within 1 month prior to dosing or planned
vaccination during the course of the study.

- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g.,
septicemia) within 3 months prior to screening.

- History of clinically significant opportunistic infection (e.g., invasive candidiasis
or one pneumocystis pneumonia).

- History of parasitic diseases (e.g., toxoplasmosis, cysticercosis, toxocariasis).

- History of frequent, recurrent herpes simplex.

- Presence of fever (body temperature greater than 37.6 °C) e.g., a fever associated
with a symptomatic viral or bacterial infection, within 2 weeks prior to the first
dosing.

- Life threatening asthmatic episode at any time in the past.

- C-reactive protein level above 5 mg/L.

- Any reason that, in the opinion of the Investigator, would prevent the subject from
participating in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Shanghai Novamab Biopharmaceuticals Co. Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is Phase I first-in-human trial evaluating the safety, tolerability, immunogenicity, and
pharmacogenomics of LQ036 via inhalation and IV infusion.

The study will be divided into 3 parts: Single Ascending Dose, Multiple Ascending Dose, and
Intra Venous with a target of 88 healthy volunteers.
Trial website
https://clinicaltrials.gov/show/NCT04993443
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Huaiyu Gu
Address 0 0
Shanghai Novamab Biopharm Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Philip Ryan, MBBS
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+61 438 009 787
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p.ryan@nucleusnetwork.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04993443