Single and Multiple Ascending Dose Study of AER-01

Last updated: June 11, 2024
Sponsor: Aer Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

AER-01

Clinical Study ID

NCT05862623
AER-01-001
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • History of unstable medical conditions or major surgical procedures over the 12months prior to Screening.

  • History or evidence of any clinically significant cardiovascular, gastrointestinal,endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excludinghistory of recurrent urinary tract infection), neurologic (excluding history ofmigraine), dermatologic, psychiatric, renal and/or other major disease ormalignancy, or any other condition that in the opinion of the PI or designee mightobfuscate the study data.

  • History of malignancy of any type, other than in situ cervical cancer or surgicallyexcised non melanomatous skin cancers, within 5 years before Screening. Part BParticipants with COPD and Moderate Airflow Limitation

  • Has evidence of significant lung restriction on pulmonary function testing or ahistory of interstitial lung disease (including sarcoidosis and idiopathic pulmonaryfibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 26, 2023
Estimated Completion Date:
August 31, 2024

Connect with a study center

  • CMAX

    Adelaide,
    Australia

    Active - Recruiting

  • Scientia Clinical Research

    Sydney,
    Australia

    Active - Recruiting

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