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

NCT07262281 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Newsoara Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weifen Zhou, Dr. · Newsoara Biopharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Australia

Study Locations

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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 NCT07262281 on ClinicalTrials.gov