drugset / Trial / NCT05378893

A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624

NCT05378893

Phase 1 Completed 153 enrolled Zhejiang Doer Biologics Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities. The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of DR10624 via subcutaneous (SubQ) injection in a randomized, placebo-controlled, double-blind study.

Timeline

Start
2022-06-22
Primary completion
2024-10-10
Completion
2025-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject DR10624 Protein / enzyme biologic Subcutaneous