NCT05862623

Single and Multiple Ascending Dose Study of AER-01

A Randomized, Double-blind, Placebo-controlled, Phase 1 Study of AER-01 (Solution for Inhalation, Delivered Via Nebulizer): As a First-In-Human Single Ascending Dose in Healthy Volunteers (Part A), and a 7-day Multiple Ascending Dose in Healthy Volunteers(Part B)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Aer Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study of AER-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and PK of AER-01. The study will be conducted in 2 parts: a single ascending dose (SAD) part in HVs (Part A) and a 7-day multiple ascending dose (MAD) part in HVs(Part B).

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	AER-01	AER-01 solution for inhalation delivered via nebulizer
DRUG	Placebo	Placebo for solution for inhalation delivered via nebulizer

Timeline

• Start date: 2023-05-26
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-05-17
• Last updated: 2024-06-13

Locations

2 sites across 1 country: Australia