Single and Multiple Ascending Dose Study of AER-01

Aer Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: COPD

Treatments: Drug: Placebo; Drug: AER-01

Study type: Interventional

Funder types: Industry

Identifiers

NCT05862623

AER-01-001

Details and patient eligibility

About

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).

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups, including a placebo group

AER-01

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: AER-01

Placebo

Placebo Comparator group

Description:

Specified dose on specified days

Treatment:

Drug: Placebo