NCT02390141

Multiple Ascending Doses of ZP4207 Administered to HV to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207

A Randomized, Placebo-controlled, Double-blind Trial of Multiple Ascending Doses of ZP4207 Administered to Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP4207

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety, tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of ZP4207 or placebo in a 3:1 treatment allocation at trial site.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	ZP4207
DRUG	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-03-17
• Last updated: 2015-11-11

Locations

1 site across 1 country: Germany