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NOT YET RECRUITING
NCT07549750
PHASE1

A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants

Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd

View on ClinicalTrials.gov

Summary

The goal of this intervention study is to evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HXN5003 in Healthy Participants.The main parameters it aims to answer are: 1. Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles? 2. Will immunogenicity of HXN5003 in healthy participants be altered? This study will be compared against a Placebo which contains the same inactive ingredients as those of HXN5003, but without the active ingredient.

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics of HXN5003 in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-05-27

Completion Date

2027-04-16

Last Updated

2026-04-24

Healthy Volunteers

Yes

Interventions

DRUG

HXN5003

Subcutaneous injection (SC) and single dose administration

DRUG

Placebo

Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration

Locations (1)

Veritus Research

Bayswater, Victoria, Australia