NCT07449741

Phase I Study of HXN6005 in Adult Healthy Participants

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HXN6005 in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants. Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug). Participants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.

Detailed description

This study consists of 5 Cohorts, including three sequential ascending-dose cohorts (Cohort 1,2 and 4), and two paralleled cohorts (Cohort 3 and 5). The investigator and participants will be blinded to treatment assignment. Participants in different dose groups will be enrolled from the low-dose group to the high-dose group. Eight healthy participants will be randomly enrolled per cohort. In cohort 1,2,4 and 5, there will be a sentinel group comprising two participants who will be randomized in a 1:1 ratio to receive either HXN6005 or placebo. In Cohort 3, eight participants will be randomized in a 6:2 ratio to receive HXN6005 or placebo. Following dosing on Day 1, blood samples will be collected according to the protocol. Participants in Cohorts 1-5 will be followed up to Day 141. The final follow-up visit will be determined based on the safety and PK data derived from the previous single ascending dose (SAD) cohorts, which may be earlier or later than Day 141 (±7 days).

Conditions

• Healthy Volunteers (HV)

Interventions

Type	Name	Description
DRUG	HXN6005	participants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4, and a single intravenous dose of HXN6005 in Cohort 5.
DRUG	Placebo	Participants will receive matching placebo across cohorts 1-5 of the study.

Timeline

• Start date: 2026-04-27
• Primary completion: 2027-03-13
• Completion: 2027-03-13
• First posted: 2026-03-04
• Last updated: 2026-03-06

Locations

1 site across 1 country: Australia