Single and Multiple Ascending Dose Study of AER-01

NCT05862623 | Unknown Phase 1

• 1 other identifier: AER-01-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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).

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum Plasma Concentration [Cmax]

  Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)

• Time to maximum concentration [Tmax]

  Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)

• 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)

Study Arms (2)

AER-01

EXPERIMENTAL

Specified dose on specified days

Drug: AER-01

Placebo

PLACEBO COMPARATOR

Specified dose on specified days

Drug: Placebo

Interventions

AER-01 DRUG

AER-01 solution for inhalation delivered via nebulizer

AER-01

Placebo DRUG

Placebo for solution for inhalation delivered via nebulizer

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers: Male or female aged ≥18 to ≤65 years.
• Current non-smoker or casual smoker Participants
• Females must not be pregnant or lactating

You may not qualify if:

• 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

Sponsors & Collaborators

• Aer Therapeutics: lead

Study Sites (2)

CMAX

Adelaide, Australia

RECRUITING

Scientia Clinical Research

Sydney, Australia

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emir Redzepagic, MD

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Low

CONTACT

919-345-4256; clinical@aertherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 17, 2023
• Study Start: May 26, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)