A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants

NCT07549750 | Not Yet Recruiting Phase 1

• 1 other identifier: HXN5003-A1-101
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles?
2. 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

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of HXN5003 in healthy participants following single dose

  Incidence of adverse events, serious adverse events; Physical examination; Vital signs; 12-lead electrocardiogram parameters; Laboratory tests

  Baseline to Day 197

Secondary Outcomes (4)

• Maximum concentration of the drug (Cmax) following single dose of HXN5003 in healthy participants

  Baseline to Day 197

• Time to peak concentration (Tmax) following single dose of HXN5003 in healthy participants

  Baseline to Day 197

• Area under the concentration-time curve from time 0 to t (AUC0-t) following single dose of HXN5003 in healthy participants

  Baseline to Day 197

• Immunogenicity evaluation of HXN5003 in healthy participants.

  Baseline to Day 197

Study Arms (8)

Cohort 0

EXPERIMENTAL

3 participants

Drug: HXN5003

Cohort 0 - Placebo

PLACEBO COMPARATOR

1 Participant

Drug: Placebo

Cohort 1

EXPERIMENTAL

6 participants

Drug: HXN5003

Cohort 1 - Placebo

PLACEBO COMPARATOR

2 participants

Drug: Placebo

Cohort 2

EXPERIMENTAL

6 participants

Drug: HXN5003

Cohort 2 - Placebo

PLACEBO COMPARATOR

2 Participants

Drug: Placebo

Cohort 3

EXPERIMENTAL

6 participants

Drug: HXN5003

Cohort 3- Placebo

PLACEBO COMPARATOR

2 Participants

Drug: Placebo

Interventions

HXN5003 DRUG

Subcutaneous injection (SC) and single dose administration

Cohort 0; Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

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

Cohort 0 - Placebo; Cohort 1 - Placebo; Cohort 2 - Placebo; Cohort 3- Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure.
• Male and female participants aged between 18 to 55 years, inclusive.
• Participants must have a body mass index between 18 to 32 kg/m2, inclusive.
• Able to participate and comply with all study procedures and restrictions
• Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.

You may not qualify if:

• Females who are pregnant, planning to become pregnant, or lactating during the trial.
• Participant who has history or evidence of any active or suspected infection within the past 14 days prior to randomization;
• Participant who has known positive tuberculin skin test or recent exposure to an individual with active tuberculosis (TB), or current clinical or laboratory evidence of active TB.
• Participant who has history of malignancy within 5 years before randomization, excluding localized basal cell carcinoma or cutaneous squamous cell carcinoma of the skin that have been resected or cured..
• Participant who has known type I/II diabetes.
• Positive for human immunodeficiency virus (HIV) antibodies, syphilis test, hepatitis B surface antigen, or hepatitis C antibodies.
• Participant who has tested positive for drugs use at Screening or before randomization;
• Participant who has used nicotine or tobacco containing products within 3 months (\>5 cigarettes or an equivalent amount of tobacco per day)
• Participant who has a history of alcohol abuse (alcohol consumption in excess of 14 units per week
• Participant who has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial;
• Participants who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing.
• Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing;
• Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID/flu) within 2 weeks prior to randomization,
• Participants with herpes zoster reactivation or cytomegalovirus (CMV) that resolved less than 60 days prior to signing informed consent.
• Abnormal renal function estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 70mL/min/1.73m2

Sponsors & Collaborators

• Helixon Biotechnology (Suzhou) Co., Ltd: lead

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Gang Tong

CONTACT

(86)13918569690; tonggang@helixon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): April 16, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)