Single and Multiple Ascending Dose Study of AER-01

Phase 1

Recruiting

• Conditions: COPD
• Interventions: Drug: AER-01; Drug: Placebo

• Registration Number: NCT05862623
• Lead Sponsor: Aer Therapeutics

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Study Start: 2023-05-26
• Status Verified: 2023-08
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

• History of unstable medical conditions or major surgical procedures over the 12 months prior to Screening.
• History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excluding history of recurrent urinary tract infection), neurologic (excluding history of migraine), dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the PI or designee might obfuscate the study data.
• History of malignancy of any type, other than in situ cervical cancer or surgically excised non melanomatous skin cancers, within 5 years before Screening. Part B Participants with COPD and Moderate Airflow Limitation
• Has evidence of significant lung restriction on pulmonary function testing or a history of interstitial lung disease (including sarcoidosis and idiopathic pulmonary fibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AER-01	AER-01	Specified dose on specified days
Placebo	Placebo	Specified dose on specified days

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)	Will be summarized by cohort, preferred term (PT), system organ class (SOC), severity, and relationship to IP.

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration [Cmax]	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)	Will be summarized using descriptive statistics by cohort, timepoint, and dose
Time to maximum concentration [Tmax]	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)	Will be summarized using descriptive statistics by cohort, timepoint, and dose
Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf]	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)	Will be summarized using descriptive statistics by cohort, timepoint, and dose

Trial Locations

Locations (2)

CMAX; 🇦🇺 Adelaide, Australia

Scientia Clinical Research; 🇦🇺 Sydney, Australia