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

NCT ID: NCT05373186

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2022-12-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BC Combo THDB0207

Single administration of BC Combo THDB0207

Group Type: EXPERIMENTAL

Euglycemic clamp with BC Combo THDB0207

Intervention Type: DRUG

Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure

Humalog® Mix25

Single administration of Humalog® Mix25

Group Type: ACTIVE_COMPARATOR

Euglycemic clamp with Humalog® Mix25

Intervention Type: DRUG

Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure

Humalog® and Lantus®

Simultaneous administration of Humalog® and Lantus®

Group Type: ACTIVE_COMPARATOR

Euglycemic clamp with Humalog® and Lantus®

Intervention Type: DRUG

Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure

Interventions

Euglycemic clamp with BC Combo THDB0207

Administration of a single dose of BC Combo THDB0207 during an euglycemic clamp procedure

Intervention Type: DRUG

Euglycemic clamp with Humalog® Mix25

Administration of a single dose of Humalog® Mix25 during an euglycemic clamp procedure

Intervention Type: DRUG

Euglycemic clamp with Humalog® and Lantus®

Simultaneous administration of Humalog® and Lantus® during an euglycemic clamp procedure

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with Chinese origin. To qualify as a subject of Chinese origin (first-generation Chinese), the subject, the subject's biological parents, and all of the subject's biological grandparents are of exclusive Chinese descent and have been born in China.
• BMI between 18.5 and 30.0 kg/m2, both inclusive.
• Fasting plasma glucose concentration <= 5.6 mmol/L (100 mg/dL).

Exclusion Criteria

• Known or suspected hypersensitivity to IMP(s) or any of the excipients or to any component of the IMP formulation.
• Receipt of any investigational medicinal product within 3 months before randomisation in this trial.

Women of childbearing potential who are not using a highly effective contraceptive method.

• Any history or presence of a life-threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
• Heart rate at rest outside the range of 50-90 beats per minute.
• History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tonghua Dongbao Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

Adocia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

CT046-ADO05

Identifier Type: -

Identifier Source: org_study_id