RecruitingPhase 1NCT06429930

Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults

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


Sponsor

Pharmosa Biopharm Inc.

Enrollment

32 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

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 dose level ranging from 15 μg to 30 μg.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 safety study for a new investigational drug called L608 in healthy adult volunteers. The study is checking how the body absorbs, processes, and tolerates different doses of the drug, and identifying any side effects. **You may be eligible if...** - You are between 18 and 65 years old - You have a body mass index (BMI) between 18.5 and 32.0 and weigh at least 50 kg - You are a non-smoker or have smoked fewer than 100 cigarettes in your lifetime and have not used tobacco products for at least 3 months - If female, you are not pregnant or breastfeeding and agree to use highly effective contraception from screening until 3 months after the last dose **You may NOT be eligible if...** - You have any allergies or sensitivities to the study drug's components - You have a history of unusual or unexplained bleeding, clotting disorders, or blood-coughing episodes - You have asthma, sleep apnea, COPD, pulmonary fibrosis, bronchiectasis, or similar breathing conditions - You have a history of serious medical conditions that could interfere with the study or your safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGL608 Liposomal inhalation suspension

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.

DRUGPlacebo 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.


Locations(1)

NZCR Ltd (New Zealand Clinical Research)

Christchurch, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06429930


Related Trials