A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants

Insmed

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Tyvaso®

Drug: Placebo

Drug: C16TR

Study type

Interventional

Funder types

Industry

Identifiers

NCT06193031

INS1009-101

Details and patient eligibility

About

The primary purpose of this study is to determine the safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Have a body weight between 50 and 120 kg (females) or between 55 and 120 kg (males), inclusive, with a body mass index (BMI) between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive, at screening.
Have a medical history, physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at screening.
Do not take any systemic or topical prescription, or nonprescription (over-the-counter [OTC]) medication (acetaminophen or ibuprofen are permitted upon principal investigator [PI] discretion) within 2 weeks or 5 half-lives (whichever is longer) before first dose of the study drugs until discharge from the study (unless prescribed by the Investigator to treat an AE).
Agree to abstain from consuming alcohol at least 3 days prior to in-clinic confinement until discharge from the study.

Exclusion criteria

Have a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
Have a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
Have a history of orthostatic hypotension, or unexplained syncope.
Have a history of additional risk factors for Torsades de Pointes (eg, heart failure, family history of Long QT Syndrome).
Are positive for human immunodeficiency virus (HIV) infection, hepatitis B surface antigen (HBsAg), or the hepatitis C virus (HCV) antibody at screening.
Are users or former users of nicotine-containing products with > 10 pack-years of tobacco use history (including but not limited to cigarettes, cigars, and chewing or dipping tobacco), or users who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 6 months before study drug administration or were using or had used topical or oral nicotine preparations for smoking cessation within the past 3 months before study drug administration.
Have a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
Have a history or current evidence of abuse of licit or illicit drugs or a positive urine test for drugs of abuse.
Have a history of abnormal bleeding tendencies.
Donated any plasma within 7 days prior to first dosing, or has donated blood in excess of 450 mL, or had significant blood loss within 56 days prior to first dosing.
Have any flu-like syndrome or other respiratory infection within 2 weeks of Day 1 or having been vaccinated with an attenuated live virus within 4 weeks of Day 1.
Have a history of major surgery within 4 weeks or minor surgery within 2 weeks of screening.

Note: Other inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

24 participants in 3 patient groups

Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo

Experimental group

Description:

Participants received a single dose of Tyvaso® on Day 1, then randomized to receive either a single dose of C16TR for inhalation (Dose A) or matching placebo on Day 2 in Cohort 1.

Treatment:

Drug: C16TR

Drug: Placebo

Drug: Tyvaso®

Cohort 2: C16TR Dose B or Placebo

Experimental group

Description:

Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2.

Treatment:

Drug: C16TR

Drug: Placebo

Cohort 3: C16TR Dose C or Placebo