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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

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

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

• 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.

• 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.

Locations
Other Locations
New Zealand
NZCR Ltd (New Zealand Clinical Research)
RECRUITING
Christchurch
Contact Information
Primary
Pei Kan, PhD
peikan@pharmosa.com.tw
+886-2-2782-7561
Backup
Sydney Chuang
sydney@pharmosa.com.tw
+886-2-2782-7561
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 56
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Pharmosa Biopharm Inc.
Collaborators: Novotech (Australia) Pty Limited

This content was sourced from clinicaltrials.gov