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RECRUITING
NCT06999720
PHASE1

Study of HX15001 in Adult Healthy Volunteers.

Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd

View on ClinicalTrials.gov

Summary

This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants. The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9). The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.

Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2025-06-11

Completion Date

2026-09-30

Last Updated

2025-08-24

Healthy Volunteers

Yes

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.

Locations (1)

Q-Pharm Pty Ltd.

Herston, Queensland, Australia