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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
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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)
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Secondary ID [1]
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AER-01-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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Assessment method [1]
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Will be summarized by cohort, preferred term (PT), system organ class (SOC), severity, and relationship to IP.
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Timepoint [1]
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Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
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Secondary outcome [1]
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Maximum Plasma Concentration [Cmax]
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Assessment method [1]
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Will be summarized using descriptive statistics by cohort, timepoint, and dose
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Timepoint [1]
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Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
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Secondary outcome [2]
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Time to maximum concentration [Tmax]
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Assessment method [2]
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Will be summarized using descriptive statistics by cohort, timepoint, and dose
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Timepoint [2]
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Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
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Secondary outcome [3]
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Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf]
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Assessment method [3]
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Will be summarized using descriptive statistics by cohort, timepoint, and dose
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Timepoint [3]
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Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
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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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/05/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2024
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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CMAX - Adelaide
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Recruitment hospital [2]
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Scientia Clinical Research - Sydney
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Aer Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05862623
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Emir Redzepagic, MD
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Address
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CMAX Clinical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kelly Otto
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Address
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Country
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Phone
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919-345-4256
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05862623
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