NCT06153329

A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects

An Open-label, Active-controlled, Randomized, Three-cycle, Crossover Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. This trial will enroll 39 subjects to receive the investigational medicinal products.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	THDB0206 injection	0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
DRUG	Humalog®	0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
DRUG	BC222insulin lispro injection	0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall

Timeline

• Start date: 2021-06-17
• Primary completion: 2022-06-06
• Completion: 2022-06-06
• First posted: 2023-12-01
• Last updated: 2023-12-01

Locations

1 site across 1 country: China