Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07281703
PHASE1

Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 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 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.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HY8931 Following Single Intravenous and Multiple Subcutaneous Doses in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-01-14

Completion Date

2026-10

Last Updated

2026-03-11

Healthy Volunteers

Yes

Conditions

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.

Locations (1)

Q-Pharm Pty Ltd.

Brisbane, Australia