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RecruitingNCT05862623Updated Jun 13, 2024

Single and Multiple Ascending Dose Study of AER-01

A Phase 1 interventional study of AER-01 and Placebo in COPD, sponsored by Aer Therapeutics. Recruiting at 2 sites in Australia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by Aer Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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).

02

Conditions studied

  • COPD
03

In context

Lead sponsor

Aer Therapeutics is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    AER-01

    Specified dose on specified days

    Drug: AER-01

  • Placebo comparator
    Placebo

    Specified dose on specified days

    Drug: Placebo

Interventions

  • DrugAER-01

    AER-01 solution for inhalation delivered via nebulizer

  • DrugPlacebo

    Placebo for solution for inhalation delivered via nebulizer

06

What researchers measure

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.

    Time frame: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)

Secondary outcomes

  1. Maximum Plasma Concentration [Cmax]

    Will be summarized using descriptive statistics by cohort, timepoint, and dose

    Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)

  2. Time to maximum concentration [Tmax]

    Will be summarized using descriptive statistics by cohort, timepoint, and dose

    Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)

  3. 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

    Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)

07

Study locations

2 of 2 sites recruiting
  • CMAX
    Adelaide, Australia
    • Emir Redzepagic, MD · Contact
    Recruiting
  • Scientia Clinical Research
    Sydney, Australia
    • Chris Argent, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05862623
Lead sponsor
Aer Therapeutics
Responsible party
Sponsor
First posted
May 17, 2023
Start date
May 26, 2023
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jun 13, 2024

Study contacts

Jordan Low
Contact
clinical@aertherapeutics.com
919-345-4256
Emir Redzepagic, MD
principal investigator · CMAX Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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