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Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants

NCT07281703 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

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 HY8931 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 HY8931 in healthy adult participants?
* What is the PK character of HY8931 following administration of single and multiple doses of HY8931 in healthy adult participants?

Researchers will compare HY8931 to a placebo (a look-alike substance that contains no drug) to see if HY8931 is safe and well tolerated.

Participants will take HY8931 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 90.

Conditions

  • Healthy

Interventions

BIOLOGICAL

HY8931

HY8931 is an injection solution with 125mg/ml per vial. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg and for subcutaneous dosing in 1 cohort of 120mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg and 360mg 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 HY8931 compared with HY8931 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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2026-09-30
Completion
2026-10-31

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 NCT07281703 on ClinicalTrials.gov