Study of HX15001 in Adult Healthy Volunteers.

PHASE1RecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

June 11, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Healthy Volunteers
Interventions
DRUG

HX15001 (SAD)

Part A (Single Ascending Dose), participants will receive a single intravenous dose of HX15001 at escalating dose levels in sequential cohorts (Cohorts 1-7).

DRUG

Placebo

Participants will receive matching placebo across cohorts 1-7 of the study.

DRUG

HX15001 (MAD)

In Part B (Multiple Ascending Dose), participants will receive multiple intravenous doses of HX15001 in cohorts 8 and 9 to assess safety, tolerability, and pharmacokinetics.

DRUG

Placebo

Participants will receive matching placebo across cohorts 8-9 of the study.

Trial Locations (1)

4006

RECRUITING

Q-Pharm Pty Ltd., Herston

All Listed Sponsors
lead

Helixon Biotechnology (Suzhou) Co., Ltd

INDUSTRY