A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants

Insmed

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Liposomal Amikacin for Inhalation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05999942

RD 201/23924

Details and patient eligibility

About

The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.

Enrollment

6 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants with a body mass index (BMI) of 20-28.
Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.
Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.

Exclusion criteria

Participants who had clinically diagnosed asthma.
Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. [^99m]Tc, or [^111]In, and [^81m]Kr).
Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction.
History of smoking within the past 12 months.
History of chronic cough or wheezing within the previous 21 days.
Participants who had an upper respiratory illness or infection within the previous 21 days.
A history of drug or alcohol abuse.
Donation of 450 milliliters (mL) or more blood within the previous 12 weeks.

Note: Other inclusion/exclusion criteria may apply.