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RECRUITING
NCT07262281
PHASE1

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

Sponsor: Newsoara Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HY6725 Following Single and Multiple Subcutaneous Doses in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2026-02-06

Completion Date

2027-04

Last Updated

2026-03-11

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

HY6725

HY6725 is an injection solution with 120mg/ml per vial. SAD part for subcutaneous dosing in 7 cohorts, including 3mg, 10mg, 30mg, 90mg, 150mg, 300mg and 450mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 150mg, 300mg and 450mg with two administrations on Day 1 and Day 30 of each cohort.

OTHER

Placebo Control

A vial with 1ml injection solution contain same ingredient except HY6725 compared with HY6725 solution.

Locations (1)

Nucleus Network Pty Ltd.

Melbourne, Australia