AER-901 Solution for Nebulization for Pulmonary Arterial Hypertension

Phase 1

Waitlist Available

Research Sponsored by Aerami Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose through 96 hours post last dose

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.

Eligible Conditions

Pulmonary Arterial Hypertension

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose through 96 hours post last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose through 96 hours post last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose through 96 hours post last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Serious Adverse Events (SAEs)

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Secondary study objectives

Systemic exposure to imatinib (in plasma) after a single administration of AER-901 (Part A)

Systemic exposure to imatinib (in plasma) after multiple administrations of AER-901 (Part B)

Systemic exposure to imatinib (in urine) after multiple administrations of AER-901 (Part B)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AER-901 Solution for NebulizationExperimental Treatment1 Intervention

The inhalation formulation AER-901 for Part A and Part B (Cohort B1 only) is a sterile, yellow solution composed of imatinib mesylate and sterile water for injection. AER-901 will be supplied in 2 solution strengths (5 mg/mL and 40 mg/mL) for nebulisation. The AER-901 inhalation formulation for Part D is a sterile yellow solution composed of imatinib mesylate, sterile water for injection and propylene glycol. AER-901 will be supplied in 2 solution strengths (5 mg/mL and 40 mg/mL) and the Pharmacy Manual will provide guidance on preparation for nebulization. Following review of the Part D safety and PK data by the SRC, the SRC will recommend which formulation and dose of AER-901 (sterile water vs propylene glycol) will be used in Parts B (Cohorts B2 and B3) and Part C. The solution will be filled into a suitable container-closure system and delivered via a nebuliser known as the FOX® MOBILE. The water acts as the medium for nebulisation.

Group II: PlaceboPlacebo Group1 Intervention

A volume-matching placebo (0.45% sterile saline for injection) is to be delivered via the FOX® MOBILE device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AER-901 Solution for Nebulization

2021

Completed Phase 1

~90

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