Single and Multiple Ascending Dose Study of AER-01

Sponsor

Aer Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05862623

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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 and subjects with COPD and moderate airflow limitation (Part B).

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: AER-01 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 and Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Moderate Airflow Limitation (Part B)

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AER-01 Specified dose on specified days	Drug: AER-01 AER-01 solution for inhalation delivered via nebulizer
Placebo Comparator: Placebo Specified dose on specified days	Drug: Placebo Placebo for solution for inhalation delivered via nebulizer

Arm

Intervention/Treatment

Experimental: AER-01

Specified dose on specified days

Drug: AER-01

AER-01 solution for inhalation delivered via nebulizer

Placebo Comparator: Placebo

Specified dose on specified days

Drug: Placebo

Placebo for solution for inhalation delivered via nebulizer

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Participants with COPD and Moderate Airflow Limitation

COPD volunteers: Male or female aged ≥35 to ≤80 years.
Documented diagnosis of moderate COPD (GOLD 2)
Former smoker with a history of at least 10 pack-years of cigarette smoking
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Aer Therapeutics

Investigators

Principal Investigator: Emir Redzepagic, MD, CMAX Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aer Therapeutics

ClinicalTrials.gov Identifier:

NCT05862623

Other Study ID Numbers:

AER-01-001

First Posted:

May 17, 2023

Last Update Posted:

May 17, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2023