A Phase 1 interventional study of HXN5003 and Placebo in Health Adult Subjects and Moderate-to-Severe Atopic Dermatitis, sponsored by Helixon Biotechnology (Suzhou) Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Helixon Biotechnology (Suzhou) Co., Ltd · Phase 1, Interventional, and Treatment
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Among 205 studies in Dermatitis, Atopic with a site in China — 64 open to participants now, 81 under way, 29 of them phase 3. Dermatitis, Atopic · China.
Among the 205 studies in Dermatitis, Atopic with a site in China, this one is the 148th largest by planned enrollment of the 189 interventional ones that give a count, is one of 31 that started in 2026, is one of 38 in phase 1, reaches primary completion later than 54 of the 80 other live ones, and was the 203rd registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 287 are open to participants now.
Browse Dermatitis, Atopic studies →64 of the 205 studies in Dermatitis, Atopic with a site in China are open now. Recruiting first, the newest first:
Galderma R&D · Sites in China
Ages 12+
Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Sites in China
Ages 18–75
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Sites in China
Ages 2–11
Innovent Biologics (Suzhou) Co. Ltd. · Sites in China
Ages 18–75
QuantX Biosciences, Inc. · Sites in China
Ages 18 mo–65 yrs · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
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 70 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.
205 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 52 · Phase 2 75 · Phase 3 63 · Phase 4 5
First in 2011; this study’s year is marked. 31 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 68 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Median enrollment 165 across the 189 interventional studies, 472 across the 16 observational. Of the 114 that completed or were terminated, 22 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
182 of 205 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.
27 of the studies in Dermatitis, Atopic with a site in China that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06775860Phase 3Beijing InnoCare Pharma Tech Co., Ltd.ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis | 2026-11-25 |
| NCT07540442Phase 3Shanghai Mabgeek Biotech.Co.LtdA Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis | 2027-01-05 |
| NCT07106372Phase 3Keymed Biosciences Co.LtdA Study of Stapokibatrt in Children Subjects With Atopic Dermatitis | 2027-02 |
| NCT06880276Phase 3Qilu Pharmaceutical Co., Ltd.Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis | 2027-03 |
| NCT07386743Phase 3Jiangsu Genscend Biopharmaceutical Co., LtdA Phase III Study of GS101 Injection to Dupixent® | 2027-04 |
Add all 27 to your calendar (.ics) → With an account.
Among the 205 studies in Dermatitis, Atopic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN5003 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).
The study consists of two parts: Part A (single ascending dose in healthy participants) and Part B (multiple ascending dose in AD patients).
The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of HXN5003.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
Healthy participants will receive a single subcutaneous dose of HXN5003
Drug: HXN5003
Healthy participants will receive a single subcutaneous dose of placebo
Drug: Placebo
AD participants will receive multiple subcutaneous doses of HXN5003
Drug: HXN5003
AD participants will receive multiple subcutaneous doses of placebo
Drug: Placebo
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of HXN5003.
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of placebo.
AD participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN5003.
AD Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Part A Adverse events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Time frame: Up to day 197
Part B Adverse Events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Time frame: Up to day 281
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Oct 2027, 13 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 13 months is close to 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 Aug 2026. You cannot join it, but the record below documents what was studied.
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Helixon Biotechnology (Suzhou) Co., Ltd →