NCT05378893

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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Zhejiang Doer Biologics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study includes 2 parts( 1 and 2). Part 1 involves a single dose of DR10624 taken as a subcutaneous injection just under the skin. Part 2 involve multiple doses of DR10624 taken as a subcutaneous injection (SC) just under the skin. Each participant will enroll in only one part.

Conditions

• Healthy, Obesity, Metabolically

Interventions

Type	Name	Description
DRUG	DR10624 for injection	administered via subcutaneous injection
DRUG	Placebo	administered via subcutaneous injection

Timeline

• Start date: 2022-06-22
• Primary completion: 2024-10-10
• Completion: 2025-01-31
• First posted: 2022-05-18
• Last updated: 2025-02-04

Locations

1 site across 1 country: New Zealand