USA001
Los Angeles, California, 91206, United States
NCT Number: NCT06193031
The primary purpose of this study is to determine the safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Los Angeles, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other inclusion/exclusion criteria may apply.
Administered as inhalation using a Philips Micro device inhaler.
Other names: Hexadecyl-treprostinil
Phosphate buffered saline (PBS) administered using Philips Micro device inhaler.
Administered as inhalation.
Other names: Inhaled treprostinil
Time frame: Up to 32 days
Safety and tolerability of escalating doses of C16TR for inhalation in healthy participants.
Time frame: At multiple timepoints post dose on Days 2 to 4
Time frame: At multiple timepoints post dose on Days 1 and 2 for Cohort 1
Pharmacokinetics of treprostinil after Tyvaso® dosing in healthy participants will be assessed.
Time frame: Baseline up to Day 4 (Cohort 1) and Day 3 (Cohorts 2, 3, 4, and 5)
Insmed Incorporated
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study of C16TR for Inhalation to Determine Its Safety, Tolerability, and Pharmacokinetics With an Open-label Tyvaso® Cohort in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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