A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-and Multiple-Ascending Subcutaneous Doses of DR10624

• Status: Not yet recruiting
• Trial end date: 2024-12-01

Summary

DR10624 is an Fc fusion protein tri-agonist with balanced GLP-1R/GCGR/FGF21R agonizing activities that complement each other in regulating blood glucose and weight. The GLP-1R agonizing activity lowers blood glucose, GCGR agonizing activity reduces body weight by increasing energy consumption, and FGF21R agonizing activity reduces blood glucose and lipid content. The development of DR10624 addresses an unmet medical need: lowering blood glucose and weight in T2D patients with a high safety margin. Additional indications, such as obesity and NASH, are also being considered.

The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of single- and multiple-ascending doses of DR10624 via SubQ injection in a randomized, placebo-controlled, double-blind study. The design and choice of the study population of the planned first-in-human (FIH) clinical Phase 1 study is based on the need to provide initial safety, tolerability, PK, and PD outcomes of DR10624 for future clinical studies. Analysis of serum concentrations from this study will characterize the single- and multiple-dose PK of DR10624 and help to refine the dosing strategy for subsequent Phase 2 multiple-dose studies.

• Phase: Phase 1

Details

• Lead Sponsor: Zhejiang Doer Biologics Corporation