NCT05373186

A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections of Humalog® and Lantus® in Healthy Chinese Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, double-dummy, active-controlled, three-period crossover euglycemic clamp trial in healthy Chinese volunteers. Each subject will be randomly allocated to one of 6 treatment sequences. Each sequence comprises one single dose of BC Combo THDB0207, one single dose of Humalog® Mix25, or simultaneous administration of Humalog® and Lantus®. Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 30-hour clamp procedures have been terminated.

Detailed description

Subjects will attend the study site in the morning in a fasted state and will be connected to an automated glucose clamp device (ClampArt). Prior to dose administration plasma glucose will be stabilised at a defined target level by means of an intravenous infusion of glucose or insulin. IMP administration will be done by an unblinded person by means of subcutaneous injections in the abdominal wall. Following each dosing a euglycaemic glucose clamp procedure will be carried out for up to 30 hours. The pharmacodynamic assessment will be based on the time course of glucose infusion rate (GIR) and plasma glucose. Plasma insulin concentrations will be measured using a specific validated bioanalytical method differentiating concentrations of insulin glargine, of its main metabolites insulin-glargine-M1 and insulin-glargine M2, and of insulin lispro. Pharmacokinetic insulin assessments will be based on total insulin concentration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Euglycemic clamp with BC Combo THDB0207	Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure
DRUG	Euglycemic clamp with Humalog® Mix25	Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure
DRUG	Euglycemic clamp with Humalog® and Lantus®	Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-12-04
• Completion: 2022-12-04
• First posted: 2022-05-13
• Last updated: 2023-10-12

Locations

1 site across 1 country: Germany