A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers
NCT03803163 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-01-14
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.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
TransCon Treprostinil
Sponsors & Collaborators
-
Ascendis Pharma A/S
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-06-30
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