NCT03279302

Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Glepaglutide	Solution for injection

Timeline

• Start date: 2017-09-04
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2017-09-12
• Last updated: 2017-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study