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

NCT05378893 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-02-04

No results posted yet for this study

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.

Conditions

  • Healthy, Obesity, Metabolically

Interventions

DRUG

DR10624 for injection

administered via subcutaneous injection

DRUG

Placebo

administered via subcutaneous injection

Sponsors & Collaborators

  • Zhejiang Doer Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Alexandra Cole, DHPharm · New Zealand Clinical Research (NZCR)

  • Yanshan Huang, PhD · Zhejiang Doer Biologics Co., Ltd.

  • Yongliang Fang, PhD · Zhejiang Doer Biologics Co., Ltd.

  • Junfang Xu, MD · Huadong Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378893 on ClinicalTrials.gov