Date: 2016-01-29
Type of information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Adocia (France) Eli Lilly (USA - IN)
Product: BioChaperone Lispro U100
Action
mechanism: insulin analogue. BioChaperone Lispro® is an ultra-fast acting formulation of insulin Lispro - Humalog® licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption.
Disease:
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On January 29, 2016, Adocia and Eli Lilly announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. The study, under the Adocia-Lilly partnership, aims to compare the pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro to that of Humalog® (insulin lispro rDNA origin) in 15 healthy Japanese subjects placed under euglycemic clamp.
In this double-blind, randomized, three-period crossover study, 15 healthy Japanese subjects placed under euglycemic clamp will receive three single dose administrations, separated by 1 to 14 days. Each subject will be randomly allocated to receive either three single doses of BioChaperone Lispro U100 (0.1, 0.2 and 0.4 U/kg) or one single dose of Humalog U100 (0.2 U/kg) and two single doses of BioChaperone Lispro U100 (0.1 and 0.2 or 0.2 and 0.4 U/kg)
on three separate dosing visits. Objectives also include the assessment of safety and tolerability of BioChaperone Lispro in these subjects. This study (EUDRACT 2015-004829-13) will be sponsored by Adocia and performed by Profil Neuss in Germany.
