COPDPhase 1NCT05862623
Single and Multiple Ascending Dose Study of AER-01
A Phase 1 study testing AER-01 in people with COPD, run by Aer Therapeutics at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- AER-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesAustralia
- Study dates
- 26 May 2023to Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers: Male or female aged ≥18 to ≤65 years.
- Current non-smoker or casual smoker Participants
- Females must not be pregnant or lactating
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
CMAX
Adelaide
Emir Redzepagic, MD
- Recruiting
Scientia Clinical Research
Sydney
Chris Argent, MD
About this study
Official 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(Part B)
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
- Being tested
- AER-01, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AER-01Drug
AER-01 solution for inhalation delivered via nebulizer
PlaceboDrug
Placebo for solution for inhalation delivered via nebulizer
| Study group | Role | What they receive |
|---|---|---|
| AER-01 | Experimental | Specified dose on specified days Receives: Drug: AER-01 |
| Placebo | Placebo comparator | Specified dose on specified days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Secondary outcomes (3)
Maximum Plasma Concentration [Cmax]
Will be summarized using descriptive statistics by cohort, timepoint, and dose
Measured: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Time to maximum concentration [Tmax]
Will be summarized using descriptive statistics by cohort, timepoint, and dose
Measured: 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]
Will be summarized using descriptive statistics by cohort, timepoint, and dose
Measured: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start26 May 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aer Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emir Redzepagic, MD, Principal investigator, CMAX Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862623
- Sponsor's protocol ID
- AER-01-001
- Status last verified
- Aug 2023
- First submitted
- 28 Apr 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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(Part B)
- ClinicalTrials.gov ID
- NCT05862623
- Acronym / sponsor ID
- AER-01-001
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Aer TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 26 May 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AER-01 | Experimental | Drug: AER-01Specified dose on specified days |
| Placebo | Placebo comparator | Drug: PlaceboSpecified dose on specified days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers: Male or female aged ≥18 to ≤65 years.
- Current non-smoker or casual smoker Participants
- Females must not be pregnant or lactating
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AER-01AER-01 solution for inhalation delivered via nebulizer | Drug | AER-01 |
| PlaceboPlacebo for solution for inhalation delivered via nebulizer | Drug | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Will be summarized by cohort, preferred term (PT), system organ class (SOC), severity, and relationship to IP.
3 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Time to maximum concentration [Tmax]
Time frame: 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]
Time frame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emir Redzepagic, MD principal investigator
CMAX Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AER-01 in people with COPD, run by Aer Therapeutics at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Low (919-345-4256, clinical@aertherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.