drugset
drugset / Trial / 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

NCT05373186 ↗

Phase 1 Completed 27 enrolled Adocia Tonghua Dongbao Pharmaceutical Co.,Ltd · collab
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Humalog® Mix25 Protein / enzyme biologic — Subcutaneous
Comparator Insulin Lispro Protein / enzyme biologic — Subcutaneous
Subject THDB0207 Unknown — Subcutaneous
Comparator insulin glargine Protein / enzyme biologic — Subcutaneous

Indications

No indication recorded.