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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05862623
Other study ID # AER-01-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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