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Atopic DermatitisPhase 1NCT07103369

A Phase I Clinical Study to Evaluate SM17 in Chinese Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis

A Phase 1 study testing SM17 for injection in people with Atopic Dermatitis, run by SinoMab BioScience Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a phase 1, randomized, double-blind, placebo-controlled trial conducted in Chinese Healthy Volunteers and Patients with moderate-to-severe Atopic Dermatitis It aims to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single and multiple doses of SM17 injection in… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
SM17 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteChina
Study dates
21 Nov 2023to 31 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Healthy Volunteers：
  • Male or Female，19~55 years old
  • BMI ≥18.5 and <28.0 kg/m² at the screening visit, with body weight ≥50 kg for males and ≥45 kg for females
  • Non-smokers or former smokers who have quit for at least 6 months, with a smoking history of <10 pack-years for former smokers at the screening visit. No history of alcohol consumption or light alcohol consumption prior to the screening visit.
  • No abnormalities or abnormalities of no clinical significance (NCS) in vital signs, physical examination, laboratory tests, or electrocardiogram (ECG) results during the screening period, QTcF <450 msec for male and QTcF <470 msec for female subjects.
  • Use one medically approved contraceptive method during the trial and for 6 months after the trial ends (specific methods see Appendix 1); No plans to donate sperm/ova during the trial and for 6 months after the trial ends.
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  • informed consent.
  • Eligible patients must have a history of inadequate response or intolerance to treatment with topical AD medications.
  • Male or female, 18 ~70 years old
  • Atopic dermatitis (Hanifin \& Rajka) at the screening visit with eczema symptoms reported over 1year
  • Eczema Area and Severity Index (EASI) score ≥16 at the screening and baseline visits
  • Investigator's Global Assessment (IGA) score ≥3 at the screening and baseline visits
  • ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits
  • Baseline pruritus numerical rating scale (NRS) weekly average score ≥4
  • Documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments are medically inadvisable (e.g. intolerance, because of important side effects, or safety risks)
  • Have applied a stable dose of topical bland emollient (moisturizer) at least twice daily for at least 7 consecutive days immediately before randomization
  • Willing and able to comply with all clinic visits and study-related procedures
  • Able to understand and complete study-related questionnaires
  • Signed written informed consent

Who cannot join

  • Healthy volunteers:
  • Presence of psychiatric or legal incapacity, significant emotional problems at the screening visit, or anticipation of such issues during the study period.
  • Regular alcohol consumption within 6 months prior to screening.
  • History or evidence of any clinically significant medical condition, situation, or disease.
  • Any laboratory parameter meeting the following criteria:
  • Total bilirubin (TBIL) >1.5 × upper limit of normal (ULN)
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  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN
  • Serum creatinine (Cr) >1.5 × ULN
  • White blood cell count below the lower limit of normal (LLN), deemed clinically significant and unsuitable for inclusion by the investigator at screening or baseline.
  • History or current diagnosis of cardiovascular/cerebrovascular disease.
  • Prior hospitalization for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
  • Evidence of any active or suspected bacterial, viral, fungal, or parasitic infection within 4 weeks prior to screening. Subjects deemed at high risk for parasitic diseases are also excluded.
  • Known diagnosis of Type I/II diabetes mellitus or prediabetes.
  • Administration of live (attenuated) vaccines within 1 month prior to first dose.
  • History of any malignancy within 5 years prior to screening (except successfully treated carcinoma in situ of the cervix or surgically excised non-melanoma skin cancer).
  • Any known history of primary or secondary immunodeficiency disorders.
  • Positive drug urine screen or alcohol consumption within 48 hours prior to screening.
  • History or presence of hypersensitivity or idiosyncratic reactions to protein therapies, drugs, any component of SM17, or related compounds.
  • Active infection including: Tuberculosis (TB), Hepatitis B, Hepatitis C, Human Immunodeficiency Virus.
  • Use of any prescription or non-prescription medication within 14 days or 5 half-lives (whichever longer) prior to first SM17 dose.
  • Tattoos, scars at/near the infusion site, or any other condition potentially interfering with infusion site examination, per investigator assessment.
  • Blood/plasma donation (≥500 mL) or significant blood loss within 2 months prior to screening; planned donation during study. Bone marrow donation within 3 months prior to first dose.
  • Inability to undergo protocol-required visits/procedures per investigator/subject knowledge.
  • Current/recent participation in another investigational drug/device study.
  • AD patients:
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
  • Laboratory abnormality for serum hemoglobulin, WBC, neutrophils, platelet, ALT/AST, TBIL, serum creatinine at screening or baseline
  • HIV/HBV/HCV/TB positive
  • ECG abnormality with clinical significance
  • History of concomitant diseases: VKC/AKC, other skin diseases, active chronic or acute infection requiring treatment with systemic medications, malignancy within 5 yrs, other major diseases
  • History of acute allergies, or known allergies to composition of monoclonal antibodies or excipients
  • Treatments within 4 weeks before the baseline visit, or is likely to require such treatment(s) during the study treatment:
  • systemic corticosteroids, Janus kinase inhibitors
  • other immunosuppressive/immunomodulating drugs (cyclosporine, mycophenolate-mofetil, IFN-γ,, azathioprine, MTX..)
  • traditional Chinese medicine
  • Treatment with TCS, TCI, PDE-4 inhibitor, or other topical AD medications within 1 week before baseline
  • New treatment of anti-histamine or ICS within 1 week before baseline ( stable doses of anti-histamine or ICS is allowed during study)
  • Treatment with biologics, within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of China Medical University

    Shenyang, Liaoning

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Preliminary Efficacy and Pharmacodynamics of SM17 in Chinese Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis

This trial is a phase 1, randomized, double-blind, placebo-controlled trial conducted in Chinese Healthy Volunteers and Patients with moderate-to-severe Atopic Dermatitis

It aims to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single and multiple doses of SM17 injection in healthy subjects . It also aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity as well as preliminary efficacy in AD patients.

Read the detailed description

This trial consists of 2 parts:

Part 1 (Ph1a) trial of the study is a dose-ascending study to evaluate the safety, tolerability, pharmacokinetic characteristics of SM17 in Chinese healthy volunteers. Safety and PK profiles of SM17 in Chinese population will be established firstly in this study following single and multiple doses of SM17 injection, and possible differences to those of SM17 in US populations will also be evaluated.

Part2 (ph1b) trial of the study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and preliminary efficacy of SM17 in treating patients with moderate-to-severe atopic dermatitis(AD) following multiple doses of SM17 injections at two doses level of SM17 or placebo. PK/PD profiles, immunogenicity profile of SM17 in AD patients will also be evaluated.

Being tested
SM17 for injection, SM17 placebo for injection
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SM17 for injectionDrug

    SM17 monoclonal antibody for intravenous infusion use

  • SM17 placebo for injectionOther

    placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein

Study groups in NCT07103369
Study groupRoleWhat they receive
SAD cohort 1Experimentalsingle ascending dose cohort 1, participants(HVs) will receive 70mg of SM17 or placebo intravenously in this cohort with randomization ratio 6:2
Receives: Drug: SM17 for injection; Other: SM17 placebo for injection
SAD cohort 2Experimentalsingle ascending dose cohort 2, participants(HVs) will receive 200mg of SM17 or placebo intravenously in this cohort with randomization ratio 6:2
Receives: Drug: SM17 for injection; Other: SM17 placebo for injection
SAD cohort 3Experimentalsingle ascending dose cohort 3, participants(HVs) will receive 600mg of SM17 or placebo intravenously in this cohort with randomization ratio 6:2
Receives: Drug: SM17 for injection; Other: SM17 placebo for injection
MD cohortExperimentalmultiple doses cohort, participants(HVs) will receive consecutive doses of 600mg of SM17 or placebo intravenously, once every 2 weeks in this cohort with randomization ratio 6:2
Receives: Drug: SM17 for injection; Other: SM17 placebo for injection
SM17 lower dose groupExperimentaltreatment group for participants (AD patients) to receive lower consecutive dose of SM17 （200mg）intravenously once every 2 weeks until end of treatment
Receives: Drug: SM17 for injection
SM17 higher dose groupExperimentaltreatment group for participants (AD patients) to receive higher consecutive dose of SM17 （200mg）intravenously once every 2 weeks until end of treatment
Receives: Drug: SM17 for injection
placebo groupPlacebo comparatorcontrol group for participants (AD patients) to receive placebo doses intravenously once every 2 weeks until end of treatment
Receives: Other: SM17 placebo for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment emergent AEs in each cohort(Ph1a)

    Safety and tolerability of SM17 in Chinese healthy volunteers administrated with SM17 or placebo intravenously. Treatment emergent AE was any unfavorable or unintended medical occurrence in each subject, including any abnormal changes in vital signs or lab testing with clinical significance judged by investigators, that happened during the period of receiving or after receiving the investigational product.

    Measured: Day 0 to Day85 (SAD cohorts), Day 0 to Day 113 (MD cohort)

  2. Incidence of Treatment emergent AEs (TEAEs) in each treatment group(ph1b)

    Safety and tolerability of SM17 in Chinese AD patients administrated with SM17 or placebo intravenously. Treatment emergent AE was any unfavorable or unintended medical occurrence in each subject, including any abnormal changes in vital signs or lab testing with clinical significance judged by investigators, that happened during the period of receiving or after receiving the investigational product. changes in vital signs and lab testing

    Measured: Week 0 to Week 16

Secondary outcomes (15)

  1. Area under the plasma concentration versus time curve (AUC) in Chinese healthy volunteers

    Serum Pharmacokinetic (PK) parameter of SM17 in Chinese healthy subjects administrated with SM17 intravenously

    Measured: 12 weeks following SM17 dose （SAD） or last dose （MD）

  2. Immunogenicity

    ADA positive rate in Chinese healthy volunteers

    Measured: Baseline to 12 weeks following SM17/placebo dose (SAD) or last dose(MD)

  3. Area under the plasma concentration versus time curve (AUC) in Chinese AD patients

    Pharmacokinetic parameter obtained from Chinese patients with moderate-to-severe AD administrated with SM17 intravenously

    Measured: Week 0 (baseline) to Week 16

  4. Efficacy for treating AD - EASI50%

    Portion of participants reaching response as EASI50(A 50% decrease in Eczema Area and Severity Index, which ranges from 0~72, and a deeper decrease means better outcome) in Chinese patients with moderate-to-severe AD administrated with SM17 intravenously

    Measured: Week12, Week 16

  5. Efficacy for treating AD-EASI75%

    Portion of participants reaching response as EASI75(A 75%50% decrease in Eczema Area and Severity Index, which ranged from 0~72, and a deeper decrease means better outcome) in Chinese patients with moderate-to-severe AD administrated with SM17 intravenously

    Measured: Week12, Week 16

  6. Efficacy for treating AD-EASI90%

    Portion of participants reaching response as EASI90(a 90% decrease in Eczema Area and Severity Index, which ranges from 0~72, and a deeper decrease means better outcome) in Chinese patients with moderate-to-severe AD administrated with SM17 intravenously

    Measured: Week12, Week 16

  7. Efficacy for treating AD-EASI score change

    EASI(Eczema Area and Severity Index) score(ranges 0~72，higher score means worse disease condition) change from baseline and percentage change from baseline in Chinese patients with moderate-to-severe AD administrated with SM17 intravenously

    Measured: Week2,4,6,8,10,12,16

  8. Efficacy for treating AD-IGA 0/1%

    Portion of participants reaching response as IGA 0/1 in Chinese patients with moderate-to-severe AD administrated with SM17 intravenously. Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™） score ranges from 0 to 4, with lower scores indicating less severe AD. IGA 0/1 is defined as scores of 0 or 1, indicating a clear or almost clear AD presentation, and with at least 2-point reduction from baseline at time of assessment.

    Measured: Week12, Week16

  9. Efficacy for treating AD- PP-NRS

    Change from baseline and Percentage change from baseline in PP-NRS weekly average score. PP-NRS is peak pruritus numeric rating scale, ranges 0~10, with higher score indicating a more severe itch condition. PP-NRS is assessed by patients to evaluate the peak pruritus condition for the past 24 hrs. A weekly average score is calculated as mean value of PP-NRS scores of 7 consecutive days prior to the point of assessments (need at least scores from 4/7 days available required to get a valid weekly average score).

    Measured: Baseline (Week0) to Week 16

  10. Efficacy for treating AD-NRS-4%

    Portion of participants reaching response as NRS-4 in Chinese patients with moderate-to-severe AD administrated with SM17 intravenously. PP-NRS is peak pruritus numeric rating scale, ranges 0~10, with higher score indicating a more severe itch condition. NRS-4 is defined as at least 4 points reduction from baseline in weekly average score of PP-NRS. A weekly average score baseline is calculated as mean value of PP-NRS scores of 7 consecutive days prior to treatments (need at least scores from 4/7 days available to get a valid weekly average score baseline).

    Measured: Week2，4，6，8，10，12，16

  11. Efficacy for treating AD-BSA%

    Change from baseline in Body Surface Area%（BSA%） with AD involvement, with a larger BSA% indicating a more severe disease condition.

    Measured: Week 2，4，6，8，10，12，16

  12. Efficacy in treating AD-SCORAD

    Change from baseline and percentage change from baseline in SCORAD (SCORing Atopic Dermatitis), ranges 0~103, with higher score indication a worse disease condition.

    Measured: Week 4，8，10，12，16

  13. Efficacy for treating AD-POEM

    Change from baseline and Percentage change from baseline in POEM (Patient-Oriented Eczema Measure scores, range 0-28), with higher score indicating a worse disease condition.

    Measured: Week2，4，6，8，10，12，16

  14. Efficacy for treating AD-DLQI

    Change from baseline in DLQI score (Dermatology Life Quality Index, range 0~30, with higher score indicating a higher disease burden).

    Measured: Week2,4,6,8,10,12,16

  15. Immunogenicity

    ADA positive rate in Chinese patients with moderate-to-severe AD treated by SM17/placebo intravenously

    Measured: Week 0~16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2025
  2. Study start21 Nov 2023
  3. Primary completion24 Mar 2025
  4. Study completion31 Mar 2025

Resources

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
Model description
Part 1: 3 single ascending dose (SAD) cohorts and 1 multiple dose (MD) cohort will be conducted sequentially, starting from the lowest dose SAD cohort, initiation of the following cohort will be upon judgement of safety review council(SRC) at least 7 days after the dosing of last cohort. Part 2: 2 doses of SM17 groups and placebo group will be enrolled and studied in parallel
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07103369
Sponsor's protocol ID
SM17-102
Other IDs
CTR20233129
Status last verified
Aug 2025
First submitted
21 Jul 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SM17 for injection in people with Atopic Dermatitis, run by SinoMab BioScience Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent AEs in each cohort(Ph1a) (time frame: Day 0 to Day85 (SAD cohorts), Day 0 to Day 113 (MD cohort)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07103369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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