drugset / Trial / NCT03803163

A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers

NCT03803163 ↗

Phase 1 Terminated 20 enrolled Ascendis Pharma A/S
NaSingle-groupOpen-labelOther

Summary

To determine the maximum tolerated dose (MTD) and assess safety and tolerability of escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection to healthy male volunteers.

Timeline

Start
2015-01
Primary completion
2015-06
Completion
2015-06

Outcome

Outcome not reported

Stopped: “Discontinued early due to local tolerance expectations not being met.”

Drugs

EvaluationDrugModalityDoseRoute
Subject TransCon Treprostinil Unknown — Subcutaneous

Indications

No indication recorded.