Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
NCT03279302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2017-12-22
Summary
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects.
Glepaglutide is a proposed International Nonproprietary Name for ZP1848
Conditions
- Healthy Subjects
Interventions
- DRUG
-
Glepaglutide
Solution for injection
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-09-04
- Primary Completion
- 2017-12-18
- Completion
- 2017-12-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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