Clinical Trial

Study of HX15001 in Adult Healthy Volunteers.

Recruiting Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-22; most recent amendment 2025-08-19.
Status change: Not Yet Recruiting → Recruiting 2025-08-19
Trial Details
NCT Number NCT06999720
Lead Sponsor Helixon Biotechnology (Suzhou) Co., Ltd
Conditions Healthy Volunteers
Enrollment 62 participants
Start Date 2025-06-11
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-24