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Single and Multiple Ascending Dose Study of AER-01

NCT05862623 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-06-13

No results posted yet for this study

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).

Conditions

Interventions

DRUG

AER-01

AER-01 solution for inhalation delivered via nebulizer

DRUG

Placebo

Placebo for solution for inhalation delivered via nebulizer

Sponsors & Collaborators

  • Aer Therapeutics

    lead INDUSTRY

Principal Investigators

  • Emir Redzepagic, MD · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05862623 on ClinicalTrials.gov