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RECRUITING
NCT06429930
PHASE1

Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults

Sponsor: Pharmosa Biopharm Inc.

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-04-11

Completion Date

2026-06-30

Last Updated

2026-01-02

Healthy Volunteers

Yes

Interventions

DRUG

L608 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.

DRUG

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.

Locations (1)

NZCR Ltd (New Zealand Clinical Research)

Christchurch, New Zealand