Atopic DermatitisPhase 1NCT07549750
A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants
A Phase 1 study testing HXN5003 in people with Atopic Dermatitis, run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- HXN5003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteAustralia
- Study dates
- 27 May 2026to 16 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- 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;
- History of any severe hypersensitivity or allergic reaction (i.e. anaphylaxis or angioedema) to any drug;
- 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.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Veritus Research
Bayswater, Victoria, 3153
Dr Emir Redzepagic, +61 3 87361750
About this study
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
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:
- Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles?
- 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
- Being tested
- HXN5003, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HXN5003Drug
Subcutaneous injection (SC) and single dose administration
PlaceboDrug
Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 0 | Experimental | 3 participants Receives: Drug: HXN5003 |
| Cohort 0 - Placebo | Placebo comparator | 1 Participant Receives: Drug: Placebo |
| Cohort 1 | Experimental | 6 participants Receives: Drug: HXN5003 |
| Cohort 1 - Placebo | Placebo comparator | 2 participants Receives: Drug: Placebo |
| Cohort 2 | Experimental | 6 participants Receives: Drug: HXN5003 |
| Cohort 2 - Placebo | Placebo comparator | 2 Participants Receives: Drug: Placebo |
| Cohort 3 | Experimental | 6 participants Receives: Drug: HXN5003 |
| Cohort 3- Placebo | Placebo comparator | 2 Participants Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Day 197
Secondary outcomes (4)
Maximum concentration of the drug (Cmax) following single dose of HXN5003 in healthy participants
Will be analyzed using standard non-compartmental analysis (NCA)
Measured: 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)
Measured: 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)
Measured: Baseline to Day 197
Immunogenicity evaluation of HXN5003 in healthy participants.
Incidence of anti-drug antibody after single ascending dose
Measured: Baseline to Day 197
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start27 May 2026 (estimated)
- Primary completion18 Mar 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549750
- Sponsor's protocol ID
- HXN5003-A1-101
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07549750
- Acronym / sponsor ID
- HXN5003-A1-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 May 2026 (estimated)
- Primary completion
- 18 Mar 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a single dose of HXN5003 in healthy participants impact the safety, tolerability and pharmacokinetic profiles?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 0 | Experimental | Drug: HXN50033 participants |
| Cohort 0 - Placebo | Placebo comparator | Drug: Placebo1 Participant |
| Cohort 1 | Experimental | Drug: HXN50036 participants |
| Cohort 1 - Placebo | Placebo comparator | Drug: Placebo2 participants |
| Cohort 2 | Experimental | Drug: HXN50036 participants |
| Cohort 2 - Placebo | Placebo comparator | Drug: Placebo2 Participants |
| Cohort 3 | Experimental | Drug: HXN50036 participants |
| Cohort 3- Placebo | Placebo comparator | Drug: Placebo2 Participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HXN5003Subcutaneous injection (SC) and single dose administration | Drug | Cohort 0, Cohort 1, Cohort 2, Cohort 3 |
| PlaceboContains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration | Drug | Cohort 0 - Placebo, Cohort 1 - Placebo, Cohort 2 - Placebo, Cohort 3- Placebo |
Primary outcome
Safety and tolerability of HXN5003 in healthy participants following single dose
Time frame: Baseline to Day 197
Incidence of adverse events, serious adverse events; Physical examination; Vital signs; 12-lead electrocardiogram parameters; Laboratory tests
4 secondary outcomes
Maximum concentration of the drug (Cmax) following single dose of HXN5003 in healthy participants
Time frame: Baseline to Day 197
Time to peak concentration (Tmax) following single dose of HXN5003 in healthy participants
Time frame: 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
Time frame: Baseline to Day 197
Immunogenicity evaluation of HXN5003 in healthy participants.
Time frame: Baseline to Day 197
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HXN5003 in people with Atopic Dermatitis, run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Tong ((86)13918569690, tonggang@helixon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of HXN5003 in healthy participants following single dose (time frame: Baseline to Day 197). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.