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Study of HX15001 in Adult Healthy Volunteers.
Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd
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
Conditions
Interventions
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).
Placebo
Participants will receive matching placebo across cohorts 1-7 of the study.
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.
Placebo
Participants will receive matching placebo across cohorts 8-9 of the study.
Locations (1)
Q-Pharm Pty Ltd.
Herston, Queensland, Australia