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

NCT05373186 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-10-12

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Tonghua Dongbao Pharmaceutical Co.,Ltd

    collaborator INDUSTRY

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Oliver Klein, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2022-12-04
Completion
2022-12-04

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373186 on ClinicalTrials.gov