NCT05862623RecruitingPhase 1
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)
Aer Therapeutics2 sites in 1 country72 target enrollmentStarted: May 26, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Study Overview
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(Part B).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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.
Arms & Interventions
AER-01
Experimental
Specified dose on specified days
Intervention: AER-01 (Drug)
Placebo
Placebo Comparator
Specified dose on specified days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Maximum Plasma Concentration [Cmax](Baseline to Day 2 (Part A), Baseline to Day 7 (Part B))
- Time to maximum concentration [Tmax](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](Baseline to Day 2 (Part A), Baseline to Day 7 (Part B))
Investigators
Study Sites (2)
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