Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05862623




Registration number
NCT05862623
Ethics application status
Date submitted
28/04/2023
Date registered
17/05/2023
Date last updated
30/08/2023

Titles & IDs
Public title
Single and Multiple Ascending Dose Study of AER-01
Scientific 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)
Secondary ID [1] 0 0
AER-01-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AER-01
Treatment: Drugs - Placebo

Experimental: AER-01 - Specified dose on specified days

Placebo Comparator: Placebo - Specified dose on specified days


Treatment: Drugs: AER-01
AER-01 solution for inhalation delivered via nebulizer

Treatment: Drugs: Placebo
Placebo for solution for inhalation delivered via nebulizer
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timepoint [1] 0 0
Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Secondary outcome [1] 0 0
Maximum Plasma Concentration [Cmax]
Timepoint [1] 0 0
Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Secondary outcome [2] 0 0
Time to maximum concentration [Tmax]
Timepoint [2] 0 0
Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Secondary outcome [3] 0 0
Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf]
Timepoint [3] 0 0
Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment hospital [2] 0 0
Scientia Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aer Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05862623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emir Redzepagic, MD
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kelly Otto
Address 0 0
Country 0 0
Phone 0 0
919-345-4256
Fax 0 0
Email 0 0
clinical@aertherapeutics.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05862623