NCT02149095

Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male Volunteers

A Phase I, Open-label, Dose Escalation Study to Determine the Maximum Tolerated Dose and Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of TransCon PEG Treprostinil Administered as a Subcutaneous Injection in Healthy Adult Male Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

TransCon PEG treprostinil is a novel prodrug form of treprostinil, in which treprostinil is reversibly conjugated via a four-arm branched polyethylene glycol (PEG) molecule. Reversible coupling of treprostinil to PEG should allow for a modified extended pharmacokinetic profile to achieve sustained plasma concentrations of treprostinil. This will be the first investigation of TransCon PEG treprostinil in humans. This study aims to determine the maximum tolerated dose (MTD) and assess the safety, tolerability and pharmacokinetics of escalating single doses of a subcutaneous injection of TransCon PEG treprostinil.

Conditions

• PAH

Interventions

Type	Name	Description
DRUG	TransCon PEG treprostinil

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-11-01
• First posted: 2014-05-29
• Last updated: 2014-08-07

Locations

1 site across 1 country: United States