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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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.
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.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →12 of the 110 studies in Dermatitis, Atopic with a site in Australia are open now. Recruiting first, the newest first:
Prana Therapies Inc · Sites in Australia, New Zealand
Ages 18–70
Bionyra Pharma · Sites in Australia
Ages 18–55 · Healthy volunteers
Seismic Therapeutic AU Pty Ltd · Sites in Australia
Ages 18–75
Zai Lab (Shanghai) Co., Ltd. · Sites in Australia, China, New Zealand
Ages 18–65 · Healthy volunteers
Inmagene LLC · Sites in Australia, United States, Canada and 1 more country
Ages 18–74
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 →
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.
110 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 44 · Phase 3 39 · Phase 4 5
First in 2003; this study’s year is marked. 6 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 28 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 226 across the 105 interventional studies, 914 across the 4 observational. Of the 81 that completed or were terminated, 56 (69%) have results posted.
This tab as a report to print or save as PDF → With an account.
104 of 110 have an industry lead sponsor. The 10 most frequent:
Helixon Biotechnology (Suzhou) Co., Ltd is the lead sponsor of 7 studies on the registry; 7 are open to participants now.
Helixon Biotechnology (Suzhou) Co., Ltd has 3 studies filed under Dermatitis, Atopic — fewer than ten, so there is no comparison to draw.
8 of the studies in Dermatitis, Atopic with a site in Australia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06241118Phase 3SanofiA Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor | 2027-09-30 |
| NCT06808477Bambusa TherapeuticsA Study of BBT001 in Healthy Volunteers (HVs) and in Adult Patients With Atopic Dermatitis (AD) | 2027-02-28 |
| NCT07549750Helixon Biotechnology (Suzhou) Co., LtdA Dose Escalation Phase 1 Study of HXN5003 in Healthy Participants | 2027-03-18 |
| NCT03992417SanofiObservational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD) | 2027-03-31 |
| NCT07217015Kymera Therapeutics, Inc.A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis | 2027-06 |
Add all 8 to your calendar (.ics) → With an account.
Among the 110 studies in Dermatitis, Atopic with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
Exclusion Criteria:
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.
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.
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.
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.
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 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 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.
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 (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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
3 participants
Drug: HXN5003
1 Participant
Drug: Placebo
6 participants
Drug: HXN5003
2 participants
Drug: Placebo
6 participants
Drug: HXN5003
2 Participants
Drug: Placebo
6 participants
Drug: HXN5003
2 Participants
Drug: Placebo
Subcutaneous injection (SC) and single dose administration
Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration
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
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
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
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
Immunogenicity evaluation of HXN5003 in healthy participants.
Incidence of anti-drug antibody after single ascending dose
Time frame: Baseline to Day 197
Plan to share: No
No publications or documents are linked to this record.
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.
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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Helixon Biotechnology (Suzhou) Co., Ltd →