NCT03735225

Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

A Randomized, Double-blind, Placebo-controlled, Doseescalation Trial to Evaluate the Safety and Tolerability of a Single IV Administration of Dasiglucagon and the Bioavailability of Dasiglucagon Following SC Compared to IV Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4 mg/mL following IV administration at increasing doses in healthy volunteers. One cohort of subjects will receive a SC dose of dasiglucagon to characterize the bioavailability of dasiglucagon following SC administration compared to IV administration. Furthermore, the trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc) prolongation via a concentrationresponse analysis.

Detailed description

Hypoglycemia in patients with diabetes is defined as episodes of an abnormally low plasma glucose concentration. Hypoglycemia is a common, unpredictable, and potentially dangerous side effect of treatment of diabetes mellitus, especially with insulin or sulfonylureas. Dasiglucagon (ZP4207) is a stable peptide analog of human glucagon, available in a ready-to-use liquid formulation. Dasiglucagon is in development for the treatment of severe hypoglycemia in patients with diabetes mellitus. Dasiglucagon is a specific and full glucagon receptor agonist designed to mimic the effects of glucagon, having a fast absorption and elimination (minutes).

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Dasiglucagon	Dasiglucagon injection
DRUG	Placebo	Placebo for Dasiglucagon injection

Timeline

• Start date: 2018-11-07
• Primary completion: 2019-06-24
• Completion: 2019-06-24
• First posted: 2018-11-08
• Last updated: 2021-03-23

Locations

1 site across 1 country: Germany