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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05112159




Registration number
NCT05112159
Ethics application status
Date submitted
16/09/2021
Date registered
8/11/2021

Titles & IDs
Public title
Study of IPG1094 in Healthy Participants
Scientific title
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Orally Administered IPG1094 in Healthy Adult Participants
Secondary ID [1] 0 0
IPG1094-A001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IPG1094
Treatment: Drugs - placebo

Experimental: IPG1094 100mg - Four subjects in this cohort will receive a single dose of IPG1094 100 mg qd and two subjects will receive a single dose of placebo 100mg qd orally. Sentinel subjects (i.e. 1 subject will be dosed with IPG1094 and 1 with placebo before the remainder of the cohort is dosed) will be used in the cohort.

Experimental: IPG1094 300mg - Six subjects in this cohort will receive a single dose of IPG1094 300 mg qd and two subjects will receive a single dose of placebo 300mg qd orally.

Experimental: IPG1094 600mg - Six subjects in this cohort will receive a single dose of IPG1094 600 mg qd and two subjects will receive a single dose of placebo 600mg qd orally.

Experimental: IPG1094 900mg - Six subjects in this cohort will receive a single dose of IPG1094 900 mg qd and two subjects will receive a single dose of placebo 900mg qd orally.

Experimental: IPG1094 1200mg - Six subjects in this cohort will receive a single dose of IPG1094 1200 mg qd and two subjects will receive a single dose of placebo 1200 mg qd orally.

Experimental: IPG1094 1500mg - Six subjects in this cohort will receive a single dose of IPG1094 1500 mg qd and two subjects will receive a single dose of placebo 1500mg qd orally.


Treatment: Drugs: IPG1094
The IPG1094 drug product is supplied as oral tablet dosage form, containing two strengths: 50 mg and 100 mg, respectively, which contain IPG1094.

Treatment: Drugs: placebo
Matching placebo tablets to IPG1094 50mg and 100mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of all adverse events
Timepoint [1] 0 0
Up to 8 days
Primary outcome [2] 0 0
RBC
Timepoint [2] 0 0
Up to 8 days
Primary outcome [3] 0 0
white blood cell count (WBC)
Timepoint [3] 0 0
Up to 8 days
Primary outcome [4] 0 0
platelet count (PLT)
Timepoint [4] 0 0
Up to 8 days
Primary outcome [5] 0 0
haemoglobin (HGB)
Timepoint [5] 0 0
Up to 8 days
Primary outcome [6] 0 0
mean corpuscular hemoglobin
Timepoint [6] 0 0
Up to 8 days
Primary outcome [7] 0 0
mean corpuscular hemoglobin concentration
Timepoint [7] 0 0
Up to 8 days
Primary outcome [8] 0 0
Hematocrit
Timepoint [8] 0 0
Up to 8 days
Primary outcome [9] 0 0
mean corpuscular volume (MCV)
Timepoint [9] 0 0
Up to 8 days
Primary outcome [10] 0 0
absolute differential leukocyte count (eosinophils)
Timepoint [10] 0 0
Up to 8 days
Primary outcome [11] 0 0
absolute differential leukocyte count (monocytes)
Timepoint [11] 0 0
Up to 8 days
Primary outcome [12] 0 0
absolute differential leukocyte count (lymphocytes)
Timepoint [12] 0 0
Up to 8 days
Primary outcome [13] 0 0
absolute differential leukocyte count (basophils)
Timepoint [13] 0 0
Up to 8 days
Primary outcome [14] 0 0
absolute differential leukocyte count (neutrophils)
Timepoint [14] 0 0
Up to 8 days
Primary outcome [15] 0 0
Temperature (°C )
Timepoint [15] 0 0
Up to 8 days
Primary outcome [16] 0 0
Respiration rate
Timepoint [16] 0 0
Up to 8 days
Primary outcome [17] 0 0
Pulse rate
Timepoint [17] 0 0
Up to 8 days
Primary outcome [18] 0 0
Blood pressure (both systolic and diastolic)
Timepoint [18] 0 0
Up to 8 days
Primary outcome [19] 0 0
Standard 12-lead ECG - heart rate
Timepoint [19] 0 0
Up to 8 days
Primary outcome [20] 0 0
Standard 12-lead ECG - QTcF
Timepoint [20] 0 0
Up to 8 days
Primary outcome [21] 0 0
Standard 12-lead ECG - PR
Timepoint [21] 0 0
Up to 8 days
Primary outcome [22] 0 0
Standard 12-lead ECG - QRS
Timepoint [22] 0 0
Up to 8 days
Primary outcome [23] 0 0
Standard 12-lead ECG - QT
Timepoint [23] 0 0
Up to 8 days
Primary outcome [24] 0 0
Alanine aminotransferase (ALT)
Timepoint [24] 0 0
Up to 8 days
Primary outcome [25] 0 0
albumin (ALB)
Timepoint [25] 0 0
Up to 8 days
Primary outcome [26] 0 0
alkaline phosphatase (ALP)
Timepoint [26] 0 0
Up to 8 days
Primary outcome [27] 0 0
aspartate aminotransferase (AST)
Timepoint [27] 0 0
Up to 8 days
Primary outcome [28] 0 0
total bilirubin (TBil)
Timepoint [28] 0 0
Up to 8 days
Primary outcome [29] 0 0
Urea
Timepoint [29] 0 0
Up to 8 days
Primary outcome [30] 0 0
calcium (Ca)
Timepoint [30] 0 0
Up to 8 days
Primary outcome [31] 0 0
chloride (Cl)
Timepoint [31] 0 0
Up to 8 days
Primary outcome [32] 0 0
cholesterol (CHO)
Timepoint [32] 0 0
Up to 8 days
Primary outcome [33] 0 0
creatinine (Cr)
Timepoint [33] 0 0
Up to 8 days
Primary outcome [34] 0 0
creatine kinase (CK)
Timepoint [34] 0 0
Up to 8 days
Primary outcome [35] 0 0
glucose (Glu)
Timepoint [35] 0 0
Up to 8 days
Primary outcome [36] 0 0
lactate dehydrogenase (LDH)
Timepoint [36] 0 0
Up to 8 days
Primary outcome [37] 0 0
phosphate (P)
Timepoint [37] 0 0
Up to 8 days
Primary outcome [38] 0 0
potassium (K)
Timepoint [38] 0 0
Up to 8 days
Primary outcome [39] 0 0
sodium (Na)
Timepoint [39] 0 0
Up to 8 days
Primary outcome [40] 0 0
total protein (TP)
Timepoint [40] 0 0
Up to 8 days
Primary outcome [41] 0 0
Prothrombin time (PT)
Timepoint [41] 0 0
Up to 8 days
Primary outcome [42] 0 0
activated partial thromboplastin time (APTT)
Timepoint [42] 0 0
Up to 8 days
Primary outcome [43] 0 0
fibrinogen
Timepoint [43] 0 0
Up to 8 days
Primary outcome [44] 0 0
international normalized ratio (INR)
Timepoint [44] 0 0
Up to 8 days
Primary outcome [45] 0 0
pH
Timepoint [45] 0 0
Up to 8 days
Primary outcome [46] 0 0
Bilirubin (U-BIL)
Timepoint [46] 0 0
Up to 8 days
Primary outcome [47] 0 0
glucose (GLU)
Timepoint [47] 0 0
Up to 8 days
Primary outcome [48] 0 0
urine erythrocytes (U-RBC)
Timepoint [48] 0 0
Up to 8 days
Primary outcome [49] 0 0
ketones (U-KET)
Timepoint [49] 0 0
Up to 8 days
Primary outcome [50] 0 0
Urinary leukocyte (U-LEU)
Timepoint [50] 0 0
Up to 8 days
Primary outcome [51] 0 0
nitrites (U-NIT)
Timepoint [51] 0 0
Up to 8 days
Primary outcome [52] 0 0
protein (U-PRO)
Timepoint [52] 0 0
Up to 8 days
Primary outcome [53] 0 0
specific gravity (U-SG)
Timepoint [53] 0 0
Up to 8 days
Primary outcome [54] 0 0
urobilinogen (URO)
Timepoint [54] 0 0
Up to 8 days
Secondary outcome [1] 0 0
Maximum plasma concentration(Cmax)
Timepoint [1] 0 0
Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary outcome [2] 0 0
Time to Cmax (tmax)
Timepoint [2] 0 0
Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary outcome [3] 0 0
Area under the serum concentration-time curve (AUC[0-t]
Timepoint [3] 0 0
Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary outcome [4] 0 0
Area under the serum concentration-infinity curve AUC[0-infinity]
Timepoint [4] 0 0
Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.
Secondary outcome [5] 0 0
Apparent terminal phase half-life (t1/2)
Timepoint [5] 0 0
Blood samples will be collected at 0 h before administration (within 1h prior to administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72, and 96 h after administration.

Eligibility
Key inclusion criteria
Participants must meet all of the following criteria to be included in the study:

Demography

1. Healthy adult male or female participants between 18 and 50 years of age (inclusive).
2. Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18~32 kg/m2 (inclusive).

Health status
3. In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests.

Vital signs (measured after resting for 5 minutes seated position) within normal range, or outside the normal range and not considered clinically significant by the Investigator.

Standard 12-lead ECG parameters (recorded after resting for 5 minutes in supine position) in the following ranges; corrected QT interval(QTc) (Fridericia algorithm recommended) = 450 ms for males and 470 ms for females, and normal ECG tracing, or abnormal ECG tracing not considered clinically relevant by the Investigator.

Laboratory parameters demonstrating no clinically significant abnormalities, as determined by the Investigator. A total bilirubin outside the normal range may be acceptable if total bilirubin does not exceed 1.5 × upper limit of normal(ULN) conjugated bilirubin (with the exception of a participant with documented Gilbert syndrome).
4. A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
5. Female participants must not be pregnant or breastfeeding and must use an effective contraception method (as described in Section 4.5.4), with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal.

A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the Investigational Medicinal Product (IMP). The participant must be excluded from the study if the serum pregnancy test is positive.

A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle stimulating hormone(FSH) measurement (> 40 IU/L or milli-International unit(mIU)/mL).Females on Hormonal Replacement therapy (HRT ), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if participants wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study.

Regulation
6. Provide written informed consent prior to undertaking any study-related procedures.
7. Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who meet any of the following criteria will be excluded from the study:

Medical history and clinical status

1. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
2. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).
3. Made a blood donation of any volume within 2 months prior to the first dose.
4. Symptomatic postural hypotension, irrespective of actual decrease in blood pressure, or asymptomatic postural hypotension with a decrease in systolic blood pressure =30 mmHg within 3 minutes of moving from supine to standing position.
5. Presence or history of drug hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician.
6. Known hypersensitivity to any component of the IMP formulation.
7. History or presence of drug or alcohol abuse (defined as alcohol consumption more than 2 units per day on a regular basis).
8. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled.
9. Excessive consumption of beverages containing xanthine bases (defined as more than 4 glasses per day).

Interfering substances
10. Any medication, including St John's Wort, within 14 days prior to administration of the first dose or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception, menopausal hormone replacement therapy, or occasional paracetamol at doses up to 2g/day.
11. Any consumption of grapefruit or products containing grapefruit within 5 days prior to the first dose administration.
12. Any vaccination in the 28 days prior to administration of the first dose.

General conditions
13. Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development.
14. Any participant who enrolled in or participated in any other clinical study involving an investigational medicinal product, or in any other type of medical research within 1 month or within 5 times the elimination half-life prior to administration of the first dose.
15. Any participant who cannot be contacted in the case of an emergency.
16. Any participant who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor.

Biological status
17. Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBcAb), anti-hepatitis C virus antibodies (anti-HCV), anti-human immunodeficiency virus 1 and 2 antibodies(anti-HIV1 and anti-HIV2 Ab).
18. Positive alcohol test.
19. Any participant in whom venous blood collection is difficult.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2022
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nanjing Immunophage Biotech Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wang Jianfei
Address 0 0
Nanjing Immunophage Biotech Co., Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zhang Qi, doctor
Address 0 0
Country 0 0
Phone 0 0
13074800770
Fax 0 0
Email 0 0
qzhang@immunophage.com.cn
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05112159