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A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants

NCT07549750 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Helixon Biotechnology (Suzhou) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2027-03-18
Completion
2027-04-16

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549750 on ClinicalTrials.gov