Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Insmed Incorporated (NASDAQ: INSM) as an inhaled therapy. It is currently in Phase 1 clinical development, studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics.
C16TR is being studied for use in healthy volunteers as part of an early-stage clinical trial. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of C16TR for inhalation when administered with a Tyvaso cohort. Its intended therapeutic use has not been established.
C16TR is being developed by Insmed Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker symbol INSM. The company is conducting a Phase 1 clinical trial of C16TR for inhalation in healthy participants in the United States.
C16TR is in Phase 1 clinical development. A single Phase 1 trial, NCT06193031, has been completed. This trial enrolled 24 healthy participants in the United States and was randomized, double-blind, and controlled. C16TR is investigational and has not been approved by regulatory authorities.
C16TR has one completed clinical trial, NCT06193031, titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants." This Phase 1 study enrolled 24 healthy adults aged 18 years and older in the United States.
No, C16TR is not the same as Tyvaso. In the clinical trial NCT06193031, C16TR for inhalation is being studied in combination with a Tyvaso cohort, indicating they are separate agents. C16TR is an investigational small molecule, while Tyvaso is a separate product used as a comparator or co-administered treatment in the study.