A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM

Summary

This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits. Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period. The total trial maximum duration for the individual subject will be up to 10 weeks.

Timeline

Start

2017-06-06

Primary completion

2017-09-04

Completion

2017-09-04

Drugs

Indications