Actively Recruiting
Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
Led by Pharmosa Biopharm Inc. · Updated on 2026-01-02
32
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
P
Pharmosa Biopharm Inc.
Lead Sponsor
N
Novotech (Australia) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with dose level ranging from 15 μg to 30 μg.
CONDITIONS
Official Title
Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged between 18 and 65 (inclusive) at the time of Screening visit.
- Body Mass Index (BMI) of 18.5 to 32.0 kg/m2 and weight of at least 50 kg at Screening.
- Non-smokers or former smokers who have smoked 100 or fewer cigarettes in their lifetime and have not used tobacco products for at least 3 months prior to Screening.
- 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.
You will not qualify if you...
- Known contraindications or sensitivity to any components of the study treatment.
- History or active condition of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, or coagulation disorders.
- History or active condition of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis, bronchospasm, or reactive airway. Childhood asthma resolved as deemed by the investigator may be considered.
- History or active condition of myocardial infarction, cerebrovascular accident, coronary artery disease, unstable angina, heart failure, significant cardiac arrhythmias, valvular heart disease with insignificant symptoms, suspected lung congestion, or pulmonary arterial hypertension caused by venous thromboembolism.
- Systolic blood pressure less than 90 mmHg or greater than 140 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 95 mmHg at Screening or check-in.
- FEV1 less than 80% predicted, FVC less than or equal to 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in.
- History of drug or alcohol abuse within 1 year prior to check-in. Regular alcohol consumption above 14 drinks per week for females and 21 drinks per week for males.
- Consumption of caffeine/methylxanthines, poppy seeds, or alcohol within 48 hours before dosing or grapefruit/pomelo within 10 days prior to drug administration, or unwillingness to refrain from alcohol from 48 hours before dosing to Day 14.
- Receipt of blood products within 2 months prior to dosing.
- Positive tests for HIV, hepatitis B, hepatitis C, or pregnancy.
- Blood donation or significant blood loss over 480 ml within 3 months prior to Screening.
- Unwillingness to refrain from strenuous exercise from 7 days prior to dosing until end of study.
- Plans to receive a tattoo, body piercing, or undergo invasive procedures during the study period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NZCR Ltd (New Zealand Clinical Research)
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
P
Pei Kan, PhD
CONTACT
S
Sydney Chuang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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