ClinicalTrials.gg
Not yet recruitingNCT07549750Updated Apr 24, 2026

A Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants

A Phase 1 interventional study of HXN5003 and Placebo in Atopic Dermatitis, sponsored by Helixon Biotechnology (Suzhou) Co., Ltd. Not yet recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Helixon Biotechnology (Suzhou) Co., Ltd · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 110 studies in Dermatitis, Atopic with a site in Australia — 12 open to participants now, 27 under way, 7 of them phase 3. Dermatitis, Atopic · Australia.

Planned enrollment
99th of 105
28 · median 226
Started
2026
with 5 others
Phase 1
19 of 110
8 open now
Primary completion
2027-03
later than 11 of 26 live
Registered
107th of 110
by date

Among the 110 studies in Dermatitis, Atopic with a site in Australia, this one is the 99th largest by planned enrollment of the 105 interventional ones that give a count, is one of 6 that started in 2026, is one of 19 in phase 1, reaches primary completion later than 11 of the 26 other live ones, and was the 107th registered.

Dermatitis, Atopic

1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.

Browse Dermatitis, Atopic studies →

Open to participants now

12 of the 110 studies in Dermatitis, Atopic with a site in Australia are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →

Who these studies take

Of the 195 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 96 (49%) stop at 75 or younger; 94 take children under 18; 52 take healthy volunteers.

This study: 18 Years to 55 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 110 studies in Dermatitis, Atopic with a site in Australia, or all of them as a file.
02

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.
03

Conditions studied

  • Atopic Dermatitis

Browse trials for

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants must sign an Institutional Review Board (IRB) approved form before any study specific procedure.
  2. Male and female participants aged between 18 to 55 years, inclusive.
  3. Participants must have a 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

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 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 (HIV) antibodies, syphilis test, surface antigen, or 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 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 .
  15. Abnormal renal function estimated calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 70mL/min/1.73m2
  16. Triplicate 12-lead (ECG) that demonstrates 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 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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Cohort 0

    3 participants

    Drug: HXN5003

  • Placebo comparator
    Cohort 0 - Placebo

    1 Participant

    Drug: Placebo

  • Experimental
    Cohort 1

    6 participants

    Drug: HXN5003

  • Placebo comparator
    Cohort 1 - Placebo

    2 participants

    Drug: Placebo

  • Experimental
    Cohort 2

    6 participants

    Drug: HXN5003

  • Placebo comparator
    Cohort 2 - Placebo

    2 Participants

    Drug: Placebo

  • Experimental
    Cohort 3

    6 participants

    Drug: HXN5003

  • Placebo comparator
    Cohort 3- Placebo

    2 Participants

    Drug: Placebo

Interventions

  • DrugHXN5003

    Subcutaneous injection (SC) and single dose administration

  • DrugPlacebo

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

06

What researchers measure

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

    Time frame: Baseline to Day 197

Secondary outcomes

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

    Will be analyzed using standard non-compartmental analysis (NCA)

    Time frame: Baseline to Day 197

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

    Will be analyzed using standard non-compartmental analysis (NCA)

    Time frame: Baseline to Day 197

  3. 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)

    Time frame: Baseline to Day 197

  4. Immunogenicity evaluation of HXN5003 in healthy participants.

    Incidence of anti-drug antibody after single ascending dose

    Time frame: Baseline to Day 197

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for Mar 2027, 9 months later.

Of 114 industry-sponsored phase 1 interventional studies under Dermatitis, Atopic, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 9 months is below that.

Counting every sponsor, half of 131 studies reached it within 13 months; a quarter within 5 and three quarters within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2026
First posted
Apr 24, 2026
StartEst.
May 27, 2026
Primary completionEst.
Mar 18, 2027
CompletionEst.
Apr 16, 2027
Last update
Apr 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07549750
Responsible party
Sponsor
First posted
Apr 24, 2026
Start date
May 27, 2026 (estimated)
Primary completion
Mar 18, 2027 (estimated)
Completion
Apr 16, 2027 (estimated)
Last update
Apr 24, 2026

Study contacts

Gang Tong
Contact
tonggang@helixon.com
(86)13918569690

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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