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drugset / Trial / NCT06153329

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

NCT06153329 ↗

Phase 1 Completed 39 enrolled Tonghua Dongbao Pharmaceutical Co.,Ltd
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2021-06-17
Primary completion
2022-06-06
Completion
2022-06-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Comparator Insulin Lispro Protein / enzyme biologic 0.2 iu/kg Subcutaneous
Subject THDB0206 Unknown 0.2 iu/kg Subcutaneous

Indications

No indication recorded.