Single and Multiple Ascending Dose Study of AER-01

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)

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05862623

Enrollment

Registered

2023-05-17

Start date

2023-05-26

Completion date

2024-08-31

Last updated

2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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).

Interventions

DRUGAER-01

AER-01 solution for inhalation delivered via nebulizer

DRUGPlacebo

Placebo for solution for inhalation delivered via nebulizer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	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

Measure	Time frame	Description
Maximum Plasma Concentration [Cmax]	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)	Will be summarized using descriptive statistics by cohort, timepoint, and dose
Time to maximum concentration [Tmax]	Baseline to Day 2 (Part A), Baseline to Day 7 (Part B)	Will be summarized using descriptive statistics by cohort, timepoint, and dose
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)	Will be summarized using descriptive statistics by cohort, timepoint, and dose

Countries

Australia

Contacts

Primary ContactJordan Low

clinical@aertherapeutics.com919-345-4256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026