A Phase 1/2 interventional study of HXN6005 and Placebo in Health Adult Subjects and Atopic Dermatitis (AD), 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 2026-08-24.
Sponsored by Helixon Biotechnology (Suzhou) Co., Ltd · Phase 1/2, 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 149th largest by planned enrollment of the 189 interventional ones that give a count, is one of 31 that started in 2026, is one of 14 in phase 1/2, reaches primary completion later than 54 of the 80 other live ones, and was the 200th 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 67 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/II, multicenter, randomized, double-blind, placebo-controlled study evaluating HXN6005 in healthy participants and patients with moderate-to-severe atopic dermatitis (AD).
The study consists of three parts: Part A (single ascending dose in healthy participants), Part B (multiple ascending dose in AD patients), and Part C (multiple-dose efficacy and safety assessment in AD patients).
The primary objectives are to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HXN6005.
Part A (Single Ascending Dose, SAD) is a randomized, double-blind, placebo-controlled, single-dose escalation design conducted in healthy participants. It includes two sequential dose cohorts. A total of 16 healthy participants are planned, with 8 participants per cohort (6 receiving HXN6005 and 2 receiving placebo). Participants receive a single subcutaneous injection of HXN6005 or placebo. All participants are followed for safety, PK, PD, and anti-drug antibody (ADA) assessments.
Part B (Multiple Ascending Dose, MAD) is a randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. Part B enrolls 16 patients across two dose cohorts, with 8 patients per cohort (6 receiving HXN6005 and 2 receiving placebo). Patients receive multiple subcutaneous injections of HXN6005 or placebo according to the study schedule.
Part C is a multicenter, randomized, double-blind, placebo-controlled study conducted in patients with moderate-to-severe AD. A total of 35 patients are planned to be randomized into two HXN6005 dose groups and one placebo group, receiving multiple subcutaneous doses according to the study schedule. Regular follow-up visits are conducted to collect efficacy data, safety data, and blood samples for assessment of systemic exposure, immunogenicity, and biomarkers.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Participants will receive a single subcutaneous dose of HXN6005
Drug: HXN6005
Participants will receive a single subcutaneous dose of placebo
Drug: Placebo
Participants will receive multiple subcutaneous doses of HXN6005
Drug: HXN6005
Participants will receive multiple subcutaneous doses of placebo
Drug: Placebo
Participants will receive multiple subcutaneous doses of HXN6005
Drug: HXN6005
Participants will receive multiple subcutaneous doses of placebo
Drug: Placebo
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive a single subcutaneous dose of placebo.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
Participants will be enrolled in parallel into one of two dose cohorts and will receive multiple subcutaneous doses of HXN6005.
Participants will be enrolled in a single cohort 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 141
Part B Adverse Events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Time frame: Up to day 197
Part C Efficacy
Change from baseline to Week 16 in the Eczema Area and Severity Index (EASI; range 0-72; higher scores indicate more severe disease) total score among AD participants
Time frame: Up to day 113
Maximum Observed Plasma Concentration (Cmax)
The maximum (peak) observed drug concentration in plasma after administration
Time frame: Up to day 197
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t)
Area under the plasma concentration-time curve from time 0 (pre-dose) to the time of the last measurable (quantifiable) plasma concentration
Time frame: Up to day 197
Incidence of antidrug antibodies (ADA) against HXN6005
The incidence of treatment-emergent ADA against HXN6005 was assessed in serum samples
Time frame: Up to day 197
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 25 industry-sponsored phase 1/2 interventional studies under Dermatitis, Atopic, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 13 months is below that.
Counting every sponsor, half of 29 studies reached it within 22 months; a quarter within 8 and three quarters within 38.
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 →