Atopic DermatitisPhase 1NCT07466940
A Clinical Study to Evaluate SM17 in Healthy Participants
A Phase 1 study testing SM17 in people with Atopic Dermatitis and Asthma, run by SinoMab BioScience Ltd at 1 site in China.
Trial summary
This is a phase I study in Chinese healthy adult volunteer participants. It aims to evaluate the safety, tolerability, PK profile and immunogenicity of a single dose of SM17 SC in healthy Chinese adult participants. It also aims to evaluate the bioavailability of SM17 SC compared to SM17 IV. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Asthma, Inflammatory Bowel Disease
- What is being tested?
- SM17
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2025to 3 Feb 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be willing to sign the ICF, and be able to complete clinical visits and study-related procedures.
- Aged 18-55 years (both inclusive) at the time of signing the ICF, regardless of sex.
- Body mass index (BMI) ≥ 18.5 and < 28.0 kg/m2, and body weight ≥ 50 kg (for males) and ≥ 45 kg (for females) at screening.
- Normal or abnormal but clinically insignificant findings in medical history and inquiries, vital signs, physical examination, laboratory tests (hematology, clinical chemistry, urinalysis, and coagulation tests), immunoglobulins, 12-lead ECG, and non-contrast chest CT at screening.
- Fertile men and women of childbearing potential must consent to use one of the highly effective contraceptive methods specified in Appendix 1 of the protocol from signing the ICF to 6 months after dosing, and have no plan to donate sperm or egg cells during this period.
Who cannot join
- Frequent alcohol consumption within 6 months prior to the screening visit, defined as an average weekly intake of > 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer, 45 mL of spirit with the alcohol content of 40%, or 150 mL of wine), inability to abstain from alcohol from the screening visit or within 48 h pre-dose until the end of study (EOS), or a positive breath alcohol test at baseline.
- Current or history of clinically significant diseases deemed by the investigator to be clinically significant or likely to interfere with the study, including but not limited to diseases related to the neurological, cardiovascular, respiratory, hematological, endocrine, genitourinary, gastrointestinal, musculoskeletal systems, etc.
- Planned major surgery during the study, major surgery within 4 weeks prior to dosing, or surgical history deemed clinically significant by the investigator.
- Smoking history (> 5 cigarettes per day on average) within 3 months prior to the screening visit, or inability to abstain from any tobacco products during the study.
- PR interval > 210 ms on 12-lead ECG or QT interval corrected for heart rate using Fridericia's formula (QTcF; see Appendix 3): QTcF ≥ 450 ms for males and QTcF ≥ 470 ms for females.
- Abnormal laboratory parameter values as follows: a) total bilirubin > 1.5 × upper limit of normal (ULN); b) alanine aminotransferase or aspartate aminotransferase > 1.5 × ULN; c) serum creatinine > ULN; d) white blood cell count below the lower limit of normal (LLN); or other abnormalities deemed by the investigator to be clinically significant, rendering the participant ineligible for enrollment.
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- Recent infections (including chronic or localized infections) within 7 days prior to the screening visit, or presence of recurrent infections that, as assessed by the investigator, may affect the interpretation of trial results.
- Received a vaccine within 1 month prior to dosing.
- History of any malignancy within 5 years prior to the screening visit.
- History of known primary or secondary immunodeficiency disorders.
- History of drug abuse prior to dosing, or positive urine drug abuse screening at baseline.
- Known allergic reactions to monoclonal antibody components or excipients, or a history of suspected hypersensitivity reactions to the study drug or any components thereof as judged by the investigator.
- Positive screen test for HIV-Ab, HBsAg, HCV-Ab, or TP-Ab at screening;
- Received any prescription drugs, over-the-counter (OTC) drugs, biological products, dietary supplements, or Chinese herbal medicines within 14 days prior to dosing or 5 half-lives (whichever is longer); participated in another clinical trial involving an investigational drug/device and received investigational treatment within 3 months prior to dosing or 5 half-lives (whichever is longer); or participated in 3 or more clinical trials of drugs/devices and received investigational treatment within the past year.
- Presence of tattoos, scars, or any other conditions at or near the injection site that, in the investigator's opinion, may interfere with injection site assessment.
- Blood (including blood products) donation or blood loss ≥ 500 mL due to surgery or trauma within 2 months prior to the screening visit; donation of hematopoietic stem cells or bone marrow within 3 months prior to dosing, or planned donation of blood, bone marrow, or hematopoietic stem cells during the study.
- History of trypanophobia or hemophobia, or cannot tolerate intravenous cannulation.
- Pregnant or lactating women, or a positive pregnancy test (for females).
- Any other conditions that, in the investigator's opinion, render the participant ineligible for the study.
- Participants who may be unable to complete the study for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SM17 Monoclonal Antibody Injection (Subcutaneous) in Chinese Healthy Participants
This is a phase I study in Chinese healthy adult volunteer participants. It aims to evaluate the safety, tolerability, PK profile and immunogenicity of a single dose of SM17 SC in healthy Chinese adult participants. It also aims to evaluate the bioavailability of SM17 SC compared to SM17 IV.
Read the detailed description
This Phase I study will be conducted in Chinese healthy adult participants to evaluate the safety, tolerability, PK, and immunogenicity of SM17 SC. This study plans to enroll a total of 30 healthy participants across 4 cohorts, among which three cohorts (n = 8 per cohort) will receive SM17 via subcutaneous injection (SC cohorts), and one cohort (n = 6) will receive SM17 via intravenous injection (IV cohort).
SM17 SC cohorts:
This part is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. A total of 24 healthy participants will be enrolled into three SC cohorts (A1 to A3), with dose levels of 195 mg, 390 mg, and 780 mg, respectively. Each cohort will enroll 8 healthy participants. Each participant will receive a single SC dose of either SM17 (n = 6) or placebo (n = 2).
SM17 IV cohort:
This part is an open-label, single-dose study. Six healthy participants will be enrolled in a single IV cohort (Cohort B) and will each receive a single intravenous injection of SM17 at a dose of 390 mg.
The SM17 SC A2 cohort and SM17 IV cohort (Cohort B) will be enrolled in parallel, and participants will be randomized to one of the two cohorts.
A dedicated Safety Review Committee (SRC) will be established for this study. The SRC is responsible for deciding whether to proceed to the next dose cohort based on a review of all relevant safety data from participants at the current dose level for at least 7 days after dosing.
- Conditions
- Atopic Dermatitis, Asthma, Inflammatory Bowel Disease
- Being tested
- SM17, SM17 placebo
- Keywords
- AD, IL-17RB, IL-25 receptor
- Medical subject headings
- Dermatitis, Atopic, Asthma, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM17Biological
SM17 monoclonal antibody
SM17 placeboDrug
placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein
| Study group | Role | What they receive |
|---|---|---|
| SM17 SC Cohort 1 | Experimental | single ascending dose cohort A1, participants will receive Dose 1 of SM17 or placebo subcutaneously with randomization ratio 3:1 Receives: Biological: SM17; Drug: SM17 placebo |
| SM17 SC Cohort22 | Experimental | single ascending dose cohort A2, participants will receive Dose2 of SM17 or placebo subcutaneously with randomization ratio 3:1 Receives: Biological: SM17; Drug: SM17 placebo |
| SM17 IV Cohort | Experimental | This is an open-label, single dose cohort B, participants will receive Dose2 of SM17 intravenously in this cohort.
The SM17 SC A2 cohort and SM17 IV cohort (Cohort B) will be enrolled in parallel, and participants will be randomized 8:6 to one of the two cohorts. Receives: Biological: SM17 |
| SM17 SC Cohort 3 | Experimental | single ascending dose cohort A3, participants will receive 780mg of SM17 or placebo subcutaneously in this cohort with randomization ratio 3:1 Receives: Biological: SM17; Drug: SM17 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent AEs
To evaluate the safety and tolerability of SM17 in Chinese healthy volunteers administrated with single dose of 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, categorized by type, severity, and causality with the study drug
Measured: Day 0 to Day 85
Secondary outcomes (8)
Area under the plasma concentration versus time curve (AUC)
To evaluate the PK parameter(AUC), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Peak Plasma Concentration (Cmax)
To evaluate the PK parameter(Cmax), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Time to peak (Tmax)
To evaluate the PK parameter(Tmax), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Elimination half-life (T1/2)
To evaluate the PK parameter(T 1/2), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Elimination Rate Constant (Kel)
To evaluate the PK parameter(Kel), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Total drug clearance from plasma (CL)
To evaluate the PK parameter(CL), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Apparent volume of distribution at steady state after extravascular administration (Vz)
To evaluate the PK parameter(Vz), which calculated from serum SM17 concentration, of a single dose of SM17 in healthy Chinese adult participants.
Measured: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Immunogenicity
To evaluate the immunogenicity of SM17 in adult healthy participants. Incidence of treatment emergent anti-drug antibodies (ADAs) during the study.
Measured: Day1, 15, 29, 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start14 Oct 2025
- Primary completion3 Feb 2026
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Sequential
- Model description
- 3 single ascending doses of SM17 will be administrated subcutaneously to Chinese Healthy volunteers, with at least 7-day post-administration safety ,tolerability and PK data reviewed under blinded condition by safety review council (SRC) meeting before dose-escalation. Each cohort of SM17 dosing consist of 6 individuals who will receive SM17 (subcutaneous injection) and the other 2 individuals who will receive matching placebo (subcutaneous injection). Another open labelled cohort of SM17 will be administrated SM17 intravenously with same dose as the second elevating dose in the SC cohorts, for studying bioavailability purpose.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SinoMab BioScience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466940
- Sponsor's protocol ID
- SM17-103
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol, TFL, CSR and related documents
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SM17 Monoclonal Antibody Injection (Subcutaneous) in Chinese Healthy Participants
- ClinicalTrials.gov ID
- NCT07466940
- Acronym / sponsor ID
- SM17-103
- Conditions
- Atopic Dermatitis, Asthma, Inflammatory Bowel Disease
- Keywords
- AD, IL-17RB, IL-25 receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SinoMab BioScience LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 3 Feb 2026 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I study in Chinese healthy adult volunteer participants. It aims to evaluate the safety, tolerability, PK profile and immunogenicity of a single dose of SM17 SC in healthy Chinese adult participants. It also aims to evaluate the bioavailability of SM17 SC compared to SM17 IV.
Detailed description
This Phase I study will be conducted in Chinese healthy adult participants to evaluate the safety, tolerability, PK, and immunogenicity of SM17 SC. This study plans to enroll a total of 30 healthy participants across 4 cohorts, among which three cohorts (n = 8 per cohort) will receive SM17 via subcutaneous injection (SC cohorts), and one cohort (n = 6) will receive SM17 via intravenous injection (IV cohort).
SM17 SC cohorts:
This part is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. A total of 24 healthy participants will be enrolled into three SC cohorts (A1 to A3), with dose levels of 195 mg, 390 mg, and 780 mg, respectively. Each cohort will enroll 8 healthy participants. Each participant will receive a single SC dose of either SM17 (n = 6) or placebo (n = 2).
SM17 IV cohort:
This part is an open-label, single-dose study. Six healthy participants will be enrolled in a single IV cohort (Cohort B) and will each receive a single intravenous injection of SM17 at a dose of 390 mg.
The SM17 SC A2 cohort and SM17 IV cohort (Cohort B) will be enrolled in parallel, and participants will be randomized to one of the two cohorts.
A dedicated Safety Review Committee (SRC) will be established for this study. The SRC is responsible for deciding whether to proceed to the next dose cohort based on a review of all relevant safety data from participants at the current dose level for at least 7 days after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 3 single ascending doses of SM17 will be administrated subcutaneously to Chinese Healthy volunteers, with at least 7-day post-administration safety ,tolerability and PK data reviewed under blinded condition by safety review council (SRC) meeting before dose-escalation. Each cohort of SM17 dosing consist of 6 individuals who will receive SM17 (subcutaneous injection) and the other 2 individuals who will receive matching placebo (subcutaneous injection). Another open labelled cohort of SM17 will be administrated SM17 intravenously with same dose as the second elevating dose in the SC cohorts, for studying bioavailability purpose.
| Arm | Type | Receives |
|---|---|---|
| SM17 SC Cohort 1 | Experimental | Biological: SM17, Drug: SM17 placebosingle ascending dose cohort A1, participants will receive Dose 1 of SM17 or placebo subcutaneously with randomization ratio 3:1 |
| SM17 SC Cohort22 | Experimental | Biological: SM17, Drug: SM17 placebosingle ascending dose cohort A2, participants will receive Dose2 of SM17 or placebo subcutaneously with randomization ratio 3:1 |
| SM17 IV Cohort | Experimental | Biological: SM17This is an open-label, single dose cohort B, participants will receive Dose2 of SM17 intravenously in this cohort. The SM17 SC A2 cohort and SM17 IV cohort (Cohort B) will be enrolled in parallel, and participants will be randomized 8:6 to one of the two cohorts. |
| SM17 SC Cohort 3 | Experimental | Biological: SM17, Drug: SM17 placebosingle ascending dose cohort A3, participants will receive 780mg of SM17 or placebo subcutaneously in this cohort with randomization ratio 3:1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be willing to sign the ICF, and be able to complete clinical visits and study-related procedures.
- Aged 18-55 years (both inclusive) at the time of signing the ICF, regardless of sex.
- Body mass index (BMI) ≥ 18.5 and < 28.0 kg/m2, and body weight ≥ 50 kg (for males) and ≥ 45 kg (for females) at screening.
- Normal or abnormal but clinically insignificant findings in medical history and inquiries, vital signs, physical examination, laboratory tests (hematology, clinical chemistry, urinalysis, and coagulation tests), immunoglobulins, 12-lead ECG, and non-contrast chest CT at screening.
- Fertile men and women of childbearing potential must consent to use one of the highly effective contraceptive methods specified in Appendix 1 of the protocol from signing the ICF to 6 months after dosing, and have no plan to donate sperm or egg cells during this period.
Key exclusion criteria (20 listed)
- Frequent alcohol consumption within 6 months prior to the screening visit, defined as an average weekly intake of > 14 units of alcohol (1 unit of alcohol ≈ 360 mL of beer, 45 mL of spirit with the alcohol content of 40%, or 150 mL of wine), inability to abstain from alcohol from the screening visit or within 48 h pre-dose until the end of study (EOS), or a positive breath alcohol test at baseline.
- Current or history of clinically significant diseases deemed by the investigator to be clinically significant or likely to interfere with the study, including but not limited to diseases related to the neurological, cardiovascular, respiratory, hematological, endocrine, genitourinary, gastrointestinal, musculoskeletal systems, etc.
- Planned major surgery during the study, major surgery within 4 weeks prior to dosing, or surgical history deemed clinically significant by the investigator.
- Smoking history (> 5 cigarettes per day on average) within 3 months prior to the screening visit, or inability to abstain from any tobacco products during the study.
- PR interval > 210 ms on 12-lead ECG or QT interval corrected for heart rate using Fridericia's formula (QTcF; see Appendix 3): QTcF ≥ 450 ms for males and QTcF ≥ 470 ms for females.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM17SM17 monoclonal antibody | Biological | SM17 IV Cohort, SM17 SC Cohort 1, SM17 SC Cohort 3, SM17 SC Cohort22 |
| SM17 placeboplacebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein | Drug | SM17 SC Cohort 1, SM17 SC Cohort 3, SM17 SC Cohort22 |
Primary outcome
Incidence of treatment emergent AEs
Time frame: Day 0 to Day 85
To evaluate the safety and tolerability of SM17 in Chinese healthy volunteers administrated with single dose of 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, categorized by type, severity, and causality with the study drug
8 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Peak Plasma Concentration (Cmax)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Time to peak (Tmax)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Elimination half-life (T1/2)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Elimination Rate Constant (Kel)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Total drug clearance from plasma (CL)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Apparent volume of distribution at steady state after extravascular administration (Vz)
Time frame: Day1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 43, 57, 85(Cohort A1, Cohort A2, Cohort A3); Day1, 2, 3, 4, 6, 8, 15, 29, 43, 57, 85(Cohort B).
Immunogenicity
Time frame: Day1, 15, 29, 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. Protocol, TFL, CSR and related documents
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SM17 in people with Atopic Dermatitis and Asthma, 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 5 inclusion and 20 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 6 Apr 2026. 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. 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 (time frame: Day 0 to Day 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.