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Also known as Hexadecyl-treprostinil
C16TR · 1 trial · 1 indication
Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Tyvaso®+C16TR Dose A or Tyvaso®+Placebo | EXPERIMENTAL | 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. |
| Cohort 2: C16TR Dose B or Placebo | EXPERIMENTAL | Participants were randomized to receive a single dose of C16TR for inhalation (Dose B) or matching placebo on Day 1 in Cohort 2. |
| Cohort 3: C16TR Dose C or Placebo | EXPERIMENTAL | Participants were randomized to receive a single dose of C16TR for inhalation (Dose C) or matching placebo on Day 1 in Cohort 3. |
| Name | Type | Description |
|---|---|---|
| C16TR | DRUG | Administered as inhalation using a Philips Micro device inhaler. |
| Placebo | DRUG | Phosphate buffered saline (PBS) administered using Philips Micro device inhaler. |
| Tyvaso® | DRUG | Administered as inhalation. |
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, electr...
C16TR is an investigational small molecule therapeutic being developed by Insmed Incorporated. It is administered by inhalation and has been studied in a Phase 1 clinical trial in healthy adult volunteers. Insmed is developing C16TR as part of its pipeline, though the specific disease indication has not been publicly disclosed.
C16TR is being developed by Insmed Incorporated, a biopharmaceutical company that trades on the Nasdaq under the ticker symbol INSM. Insmed is the sponsor of the clinical program evaluating C16TR.
C16TR is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA for any indication.
C16TR has been evaluated in one completed Phase 1 trial, NCT06193031, titled a study to evaluate the safety, tolerability, and pharmacokinetics of C16TR for inhalation with a Tyvaso cohort in healthy participants. The trial enrolled 24 healthy adult volunteers in the United States and used a randomized, double-blind, controlled design.
C16TR is administered by inhalation. The completed Phase 1 trial NCT06193031 evaluated C16TR for inhalation in healthy participants, and the study was designed to assess safety, tolerability, and pharmacokinetics of the inhaled formulation.