A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: HXN5003; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gang Tong; Phone Number: (86)13918569690; Email: tonggang@helixon.com

Study Locations

• Australia
  • Victoria
    • Bayswater, Victoria, Australia, 3153
      • Veritus Research
      • Contact: Dr Emir Redzepagic; Phone Number: +61 3 87361750

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Females who are pregnant, planning to become pregnant, or lactating during the trial.
2. Participant who has history or evidence of any active or suspected infection within the past 14 days prior to randomization;
3. 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.
4. 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..
5. Participant who has known type I/II diabetes.
6. Positive for human immunodeficiency virus (HIV) antibodies, syphilis test, hepatitis B surface antigen, or hepatitis C antibodies.
7. Participant who has tested positive for drugs use at Screening or before randomization;
8. Participant who has used nicotine or tobacco containing products within 3 months (>5 cigarettes or an equivalent amount of tobacco per day)
9. Participant who has a history of alcohol abuse (alcohol consumption in excess of 14 units per week
10. 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;
11. Participants who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing.
12. 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;
13. Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID/flu) within 2 weeks prior to randomization,
14. Participants with herpes zoster reactivation or cytomegalovirus (CMV) that resolved less than 60 days prior to signing informed consent.
15. Abnormal renal function estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation < 70mL/min/1.73m2
16. Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
17. Participant who has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to randomization, or plan to have any surgeries during the duration the trial;
18. History of any severe hypersensitivity or allergic reaction (i.e. anaphylaxis or angioedema) to any drug;
19. History of, or current, clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurologic, psychiatric, immunologic, Gilbert's Syndrome and allergic disease or any other condition, in the opinion of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of study drug; or place the participant at risk in this study or interfere with the interpretation of data.
20. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 6 participants	Drug: HXN5003; Subcutaneous injection (SC) and single dose administration
Experimental: Cohort 2; 6 participants	Drug: HXN5003; Subcutaneous injection (SC) and single dose administration
Experimental: Cohort 3; 6 participants	Drug: HXN5003; Subcutaneous injection (SC) and single dose administration
Experimental: Cohort 0; 3 participants	Drug: HXN5003; Subcutaneous injection (SC) and single dose administration
Placebo Comparator: Cohort 0 - Placebo; 1 Participant	Drug: Placebo; Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration
Placebo Comparator: Cohort 1 - Placebo; 2 participants	Drug: Placebo; Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration
Placebo Comparator: Cohort 2 - Placebo; 2 Participants	Drug: Placebo; Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration
Placebo Comparator: Cohort 3- Placebo; 2 Participants	Drug: Placebo; Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration of the drug (Cmax) following single dose of HXN5003 in healthy participants	Will be analyzed using standard non-compartmental analysis (NCA)	Baseline to Day 197
Time to peak concentration (Tmax) following single dose of HXN5003 in healthy participants	Will be analyzed using standard non-compartmental analysis (NCA)	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	Will be analyzed using standard non-compartmental analysis (NCA)	Baseline to Day 197
Immunogenicity evaluation of HXN5003 in healthy participants.	Incidence of anti-drug antibody after single ascending dose	Baseline to Day 197

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): March 18, 2027
• Study Completion (Estimated): April 16, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: HXN5003-A1-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No