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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/NCT06429930




Registration number
NCT06429930
Ethics application status
Date submitted
21/05/2024
Date registered
28/05/2024
Date last updated
28/05/2024

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
Scientific title
A Phase 1, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Participants
Secondary ID [1] 0 0
PBI-L608-B12
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
Cardiovascular 0 0 0 0
Hypertension

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

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

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


Treatment: Drugs: L608 Liposomal inhalation solution
Participants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the rest of the cohort to receive the assigned dose of L608 or placebo.

Treatment: Drugs: Placebo Solution
Participants will be randomized at a ratio of 1:1 (for sentinel dosing) followed by 5:1 for the 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
Percentage of participants with DLT
Timepoint [1] 0 0
7 days after administration
Primary outcome [2] 0 0
Percentage of participants with TEAEs and SAEs
Timepoint [2] 0 0
2 weeks after administration
Primary outcome [3] 0 0
Frequency and severity of TEAEs and SAEs
Timepoint [3] 0 0
2 weeks after administration
Secondary outcome [1] 0 0
AUC0-t
Timepoint [1] 0 0
24 hours after administration
Secondary outcome [2] 0 0
AUC0-inf
Timepoint [2] 0 0
24 hours after administration
Secondary outcome [3] 0 0
%AUCextrap
Timepoint [3] 0 0
24 hours after administration
Secondary outcome [4] 0 0
Cmax
Timepoint [4] 0 0
24 hours after administration
Secondary outcome [5] 0 0
Tmax
Timepoint [5] 0 0
24 hours after administration
Secondary outcome [6] 0 0
T1/2
Timepoint [6] 0 0
24 hours after administration
Secondary outcome [7] 0 0
CL/F
Timepoint [7] 0 0
24 hours after administration
Secondary outcome [8] 0 0
Vz/F
Timepoint [8] 0 0
24 hours after administration
Secondary outcome [9] 0 0
?z
Timepoint [9] 0 0
24 hours after administration
Secondary outcome [10] 0 0
Cmax/D
Timepoint [10] 0 0
24 hours after administration
Secondary outcome [11] 0 0
AUC0-t/D
Timepoint [11] 0 0
24 hours after administration
Secondary outcome [12] 0 0
AUC0-inf/D
Timepoint [12] 0 0
24 hours after administration

Eligibility
Key inclusion criteria
Key

1. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.

2. Participants with Body Mass Index (BMI) of =18.5 and =32.0 kg/m2 and weight of at
least 50 kg at Screening.

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. Participants with contraindications or sensitivity to any components of the study
treatment.

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

3. Participants 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.

4. Participants 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.

5. Participants with systolic blood pressure < 90 mmHg or > 140 mmHg and/or diastolic
blood pressure < 50 mmHg or > 95 mmHg at Screening or check-in visit.

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

7. Participants with histories of drug or alcohol abuse within 1 year prior to subject
check-in (Day -1). Regular alcohol consumption defined as > 14 standard drinks per
week for female and > 21 standard drinks per week for male.

8. 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, and/or participants unwilling to refrain from consumption of alcohol
from 48 hours before dosing to Day 14.

9. Receipt of blood products within 2 months prior to dosing.

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

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

12. Participants unwilling to refrain from strenuous exercises from 7 days prior to dosing
until the EOS visit.

13. Participants planning to receive a tattoo, body piercing, or undergo any invasive
procedure during the study period.

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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
Brief summary
This is the second single ascending dose study of L608 in healthy participants and is being
conducted to evaluate the safety of L608 with higher dose levels, starting from 20 µg and
escalating up to a planned maximum dose of 110 µg.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06429930
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
+886-2-2782-7561
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06429930