drugset
drugset / Trial / NCT07262281

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult Participants

NCT07262281 ↗

Phase 1 Recruiting 74 enrolled Newsoara Biopharma Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

Summary

The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY6725 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY6725 in healthy adult participants? * What is the PK character of HY6725 following administration of single and multiple doses of HY6725 in healthy adult participants? Researchers will compare HY6725 to a placebo (a look-alike substance that contains no drug) to see if HY6725 is safe and well tolerated. Participants will take HY6725 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 150.

Timeline

Start
2026-02-06
Primary completion
2027-03
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HY6725 Monoclonal antibody 3 mg Subcutaneous
Subject HY6725 Monoclonal antibody 10 mg Subcutaneous
Subject HY6725 Monoclonal antibody 30 mg Subcutaneous
Subject HY6725 Monoclonal antibody 90 mg Subcutaneous
Subject HY6725 Monoclonal antibody 150 mg Subcutaneous
Subject HY6725 Monoclonal antibody 300 mg Subcutaneous
Subject HY6725 Monoclonal antibody 450 mg Subcutaneous

Indications

No indication recorded.