Single and Multiple Ascending Dose Study of AER-01

COPD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862623
• Other study ID #: AER-01-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 26, 2023
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Aer Therapeutics
• Contact: Jordan Low
• Phone: 919-345-4256
• Email: clinical[@]aertherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria Health Volunteers:

• Healthy volunteers: Male or female aged =18 to =65 years.

• Current non-smoker or casual smoker Participants

• Females must not be pregnant or lactating

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.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• AER-01
AER-01 solution for inhalation delivered via nebulizer
• Placebo
Placebo for solution for inhalation delivered via nebulizer

Locations

Country	Name	City	State
Australia	CMAX	Adelaide
Australia	Scientia Clinical Research	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Aer Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Will be summarized by cohort, preferred term (PT), system organ class (SOC), severity, and relationship to IP.	Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Secondary	Maximum Plasma Concentration [Cmax]	Will be summarized using descriptive statistics by cohort, timepoint, and dose	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Secondary	Time to maximum concentration [Tmax]	Will be summarized using descriptive statistics by cohort, timepoint, and dose	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Secondary	Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf]	Will be summarized using descriptive statistics by cohort, timepoint, and dose	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)