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Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution

NCT04903730 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-12-07

No results posted yet for this study

Summary

This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult volunteers. This study consists of 3 parts and an optional fourth part.

Conditions

Interventions

DRUG

AER-901 Solution for Nebulization

Part A: participants will be enrolled into 1 of up to 5 sequential cohorts (A1 to A5). Inhaled AER-901 doses of 5, 10, 20, 40, and 80mg are planned. Part B: participants will be enrolled into 1 of up to 3 cohorts (B1 to B3). Cohorts B2 and B3 will commence following Part D of the study and following SRC review of safety, tolerability, and PK data. A decision to dose with either a propylene glycol formulation or a sterile water formulation will be made by the SRC at the time of the review of the Part D data. Part D has a three-part design (Treatment Periods 1 \& 2 separated by a Washout period) and will compare placebo to a single-dose of AER-901 (5 mg/mL QD) followed by two doses of AER-901. Each cohort will consist of 8 participants (6 receiving AER 901 and 2 receiving placebo).

DRUG

Placebo

0.45% sterile saline for injection delivered via the FOX MOBILE device.

Sponsors & Collaborators

  • Aerami Therapeutics

    lead INDUSTRY

Principal Investigators

  • Lisa Yanez · Chief Operating Officer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2022-12-02
Completion
2022-12-02

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 NCT04903730 on ClinicalTrials.gov