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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05938946




Registration number
NCT05938946
Ethics application status
Date submitted
9/06/2023
Date registered
11/07/2023
Date last updated
28/02/2024

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults
Scientific title
A Phase I, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Subjects
Secondary ID [1] 0 0
PBI L608p1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - L608 Inhalation Solution
Treatment: Drugs - Placebo solution

Experimental: L608 Liposomal inhalation solution - Eight subjects will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2).

Experimental: Placebo - Eight subjects will be enrolled in each cohort and be randomized to receive assigned dose of L608 or placebo (6:2).


Treatment: Drugs: L608 Inhalation Solution
subjects will be randomized at a ratio of 1:1 (for Sentinel dosing) followed by 5:1 for rest of the cohort to receive the assigned dose of L608 or placebo

Treatment: Drugs: Placebo solution
subjects will be randomized at a ratio of 1:1 (for Sentinel dosing) followed by 5:1 for rest of the cohort to receive the assigned dose of L608 or placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence of dose limiting toxicity (DLT)
Timepoint [1] 0 0
Baseline to Day 14
Primary outcome [2] 0 0
The incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [2] 0 0
Baseline to Day 21
Primary outcome [3] 0 0
Frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [3] 0 0
Baseline to Day 21
Secondary outcome [1] 0 0
AUC0-t
Timepoint [1] 0 0
Baseline to 24 hours
Secondary outcome [2] 0 0
AUC0-8
Timepoint [2] 0 0
Baseline to 24 hours
Secondary outcome [3] 0 0
%AUCextrap
Timepoint [3] 0 0
Baseline to 24 hours
Secondary outcome [4] 0 0
Cmax
Timepoint [4] 0 0
Baseline to 24 hours
Secondary outcome [5] 0 0
Tmax
Timepoint [5] 0 0
Baseline to 24 hours
Secondary outcome [6] 0 0
T1/2
Timepoint [6] 0 0
Baseline to 24 hours
Secondary outcome [7] 0 0
CL/F
Timepoint [7] 0 0
Baseline to 24 hours
Secondary outcome [8] 0 0
Vz/F
Timepoint [8] 0 0
Baseline to 24 hours
Secondary outcome [9] 0 0
kel
Timepoint [9] 0 0
Baseline to 24 hours

Eligibility
Key inclusion criteria
Key

1. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
Females must not be pregnant or lactating.

2. Body Mass Index (BMI) of =18.5 and =30.0 kg/m2

3. Non-smokers or former smokers who have smoked = 100 cigarettes in their lifetime and
have not consumed any tobacco or tobacco-containing products for at least 3 months
prior to Screening.

4. Females must not be pregnant or lactating and must use acceptable, highly effective
double contraception from Screening until 3 months after the last dose of the
Investigational product.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects with contraindications or sensitivity to any components of the study
treatment.

2. Subjects with medical histories (within 3 months prior to Screening) or ongoing
conditions of any clinically significant and/or any other medical conditions which may
jeopardize the safety of the subjects and/or effect the results of the study at the
Investigator's discretion.

3. Subjects with histories or active conditions of unexplained bleeding events,
hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders.

4. Subjects who voluntarily participate in this study and sign the informed consent form
prior to any study procedures.

5. Subjects with histories or active conditions of asthma, sleep apnea, chronic
obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis,
bronchospasm, and/or reactive airway. Subjects who have had childhood asthma which
have resolved as deemed by the PI can be considered.

6. Subjects with histories or active conditions of myocardial infarction (MI),
cerebrovascular accident (CVA), coronary artery disease (CAD), unstable angina, heart
failure, significant cardiac arrhythmias, congenital or acquired valvular heart
disease with clinically insignificant symptom, suspected lung congestion, and/or
pulmonary arterial hypertension (PAH) causing by venous thromboembolism.

7. Subjects with systolic blood pressure < 90 mmHg or > 160 mmHg and/or diastolic blood
pressure < 50 mmHg or > 95 mmHg at Screening or check-in visit.

8. Subjects with FEV1 less than 80% predicted, FVC ?80% predicted, or resting oxygen
saturation less than 95% at Screening or check-in visit.

9. Subjects with histories of drug or alcohol abuse within 1 year prior to subject
check-in (Day -1). Regular alcohol consumption defined as > 10 standard drinks per
week.

10. Consumption of products containing caffeine/methylxanthines, poppy seeds and/or
alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo
(shown to inhibit cytochrome P450 [CYP] 3A4 activity) within 10 days prior to drug
administration.

11. Positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV),
hepatitis C virus (HCV), and pregnancy test.

12. Blood donation or significant blood loss (>480 ml) within 3 months prior to Screening.

13. Subjects are pregnant or breast feeding.

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
Single group
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
30/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmosa Biopharm Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase I, randomized, double-blinded, placebo-controlled single ascending dose,
sequential-group study to evaluate the safety, tolerability, and PK of single ascending doses
of L608 inhalation in healthy volunteers.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05938946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pei Kan, PhD
Address 0 0
Country 0 0
Phone 0 0
886-2782-7561
Fax 0 0
Email 0 0
peikan@pharmosa.com.tw
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05938946