Health Adult SubjectsPhase 1NCT07801612
A Phase I Study of HXN5003 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
A Phase 1 study testing HXN5003 in people with Health Adult Subjects and Moderate-to-Severe Atopic Dermatitis, run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects, Moderate-to-Severe 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
- 68 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Jan 2028
- Phase
- Phase 1
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF).
- (Healthy Participants) Male or female participants aged 18 to 50 years (inclusive) at the time of signing the ICF.
- (Healthy Participants) Male participants weighing ≥ 50.0 kg and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive).
- (Patients with AD) Male or female participants aged 18 to 70 years (inclusive)
- (Patients with AD) Participants must have documented AD history, moderate-to-severe disease, and inadequate response to topical therapy at screening.
Who cannot join
- Presence of any clinically significant disease at randomization, as judged by the investigator.
- History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc.
- Known or suspected history of immunosuppression, or history of invasive opportunistic infections, including infections that are unusually frequent, recurrent, or prolonged in duration as judged by the investigator, even after resolution of the infection.
- Participants who have resided long-term in regions with high prevalence of Human Herpesvirus-8 (HHV-8), such as Africa or the Mediterranean coastal areas.
- History of malignancy or malignant disease, with the exception of surgically excised cutaneous squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ that have been in complete remission for more than 5 years without any evidence of recurrence.
- Female participants who are breastfeeding or pregnant, or women of childbearing potential with a positive serum pregnancy test result at screening.
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- Participants with a chronic active infection or a condition that would seriously interfere with study drug administration at baseline within 4 weeks prior to randomization; or a superficial skin infection requiring treatment within 1 week prior to randomization; or an acute illness within 48 hours prior to randomization.
- (Patients with AD) Other than AD, A history of clinically significant disease which is poorly controlled or could pose a safety risk to the participant or confound the safety assessment, as judged by the Investigator to compromise participant safety in the study.
- (Patients with AD) Positive results in any of the following infectious disease screening tests: 1）History of active tuberculosis, or positive result at screening (T-SPOT.TB or QuantiFERON-TB Gold); 2）Positive for hepatitis B; 3）Positive hepatitis C antibody; 4）Positive Treponema pallidum antibody; 5）History of HIV infection, or positive HIV antibody.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, 310006
Liming Wu, 13750837205, 18957118053@163.com
Ying Wang, (86)-18367124548, nancywangying@163.com
About this study
Official title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of HXN5003 in Healthy Participants and Patients With Moderate-to-Severe Atopic Dermatitis
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.
- Being tested
- HXN5003, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HXN5003Drug
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of HXN5003.
PlaceboDrug
Healthy participants will be enrolled sequentially into one of four ascending dose cohorts and will receive a single subcutaneous dose of placebo.
HXN5003Drug
AD participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of HXN5003.
PlaceboDrug
AD Participants will be enrolled sequentially into one of two ascending dose cohorts and will receive multiple subcutaneous doses of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Part A Single Ascending Dose (SAD) | Experimental | Healthy participants will receive a single subcutaneous dose of HXN5003 Receives: Drug: HXN5003 |
| Part A Placebo (SAD) | Placebo comparator | Healthy participants will receive a single subcutaneous dose of placebo Receives: Drug: Placebo |
| Part B Multiple Ascending Dose (MAD) | Experimental | AD participants will receive multiple subcutaneous doses of HXN5003 Receives: Drug: HXN5003 |
| Part B Placebo (MAD) | Placebo comparator | AD participants will receive multiple subcutaneous doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Adverse events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Measured: Up to day 197
Part B Adverse Events
Incidence, severity, and causal relationship of Adverse Events (AEs)
Measured: Up to day 281
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 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
- NCT07801612
- Sponsor's protocol ID
- HXN5003-A1-102
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No