Clinical trial NCT05862623: Single and Multiple Ascending Dose Study of AER-01
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: COPD
Lead sponsor: Aer Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Baseline to Day 2 (Part A), Baseline to Day 8 (Part B)
Secondary outcomes:
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
measure: Time to maximum concentration [Tmax]
timeFrame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
measure: Area under the drug concentration-time curve from time 0 (time of dosing) extrapolated to infinity [AUC 0-inf]
timeFrame: Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
city: Sydney
country: Australia
facility: Scientia Clinical Research
Study officials:
affiliation: CMAX Clinical Research
name: Emir Redzepagic, MD
role: PRINCIPAL_INVESTIGATOR
References: