Plaque PsoriasisPhase 1/2MECAPNCT07129382
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
A Phase 1/2 study testing CS32582 capsule（low dose）, CS32582 capsule（medium dose） and CS32582 capsule（high dose） in people with Plaque Psoriasis, run by Chipscreen Biosciences, Ltd. at 11 sites in China.
Trial summary
" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- CS32582 capsule（low dose）, CS32582 capsule（medium dose） and CS32582 capsule（high dose）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 11 sitesChina
- Study dates
- 8 Sep 2025to 18 Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form (ICF) after fully understanding the trial.
- Age 18-70 years (inclusive) at consent, any gender
- Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening.
- Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed).
- Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%;
- Candidate for phototherapy or systemic therapy per investigator's judgment.
- Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose.
Who cannot join
- Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) .
- Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment.
- Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.
- History of severe drug allergies.
- Major surgery within 2 months before randomization or planned during the study.
- Drug/alcohol abuse within 6 months before screening.
Show all 43Show fewer
- Uncontrolled hypertension at screening (SBP >160 mmHg or DBP >100 mmHg).
- Myocardial infarction, unstable angina, TIA, stroke, PCI, or CABG within 6 months before screening.
- NYHA Class III/IV heart failure at screening.
- History of malignancy or lymphoproliferative disorders within 5 years (exceptions: basal cell carcinoma, localized squamous cell carcinoma, or cervical carcinoma in situ cured ≥1 year).
- Prosthetic joint infection (unless prosthesis removed/replaced ≥2 months before randomization).
- History of opportunistic infections (e.g., PJP, histoplasmosis, coccidioidomycosis).
- Active/latent TB infection (positive IGRA without clinical manifestations).
- Herpes infection:a) Active herpes zoster/simplex (HSV-1/2) at screening;b) History of severe herpes (disseminated disease, multidermatomal HSV, encephalitis, ophthalmic herpes, or recurrent zoster [≥2 episodes in 2 years]).
- History of severe bacterial, fungal, or viral infection requiring hospitalization for IV antibiotic or antiviral administration within 2 months before randomization.
- History of live vaccine administration within 2 months before randomization or plans to receive a live vaccine during the study period.
- Evidence of active infection and/or febrile illness requiring systemic anti-infective therapy within 2 weeks before randomization.
- Abnormal virology at screening:
- HBsAg(+) or HBcAb(+) with detectable HBV-DNA
- HCV Ab(+) with detectable HCV-RNA
- History of HIV infection or HIV Ab(+)
- Treponema pallidum Ab(+) with positive RPR/TRUST
- Prior use of TYK2 inhibitors (e.g., deucravacitinib).
- Use of any of the following therapeutic agents within 6 months before randomization:
- IL-12/23, IL-17, or IL-23 inhibitors (ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab)
- Rituximab or other B-cell depleting agents
- Leflunomide
- Use of any of the following therapeutic agents within 3 months before randomization: Integrin pathway modulators (natalizumab) or B/T-cell modulators (alemtuzumab, abatacept, vedolizumab).
- Use of TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab) within 2 months before randomization.
- Any biologic psoriasis therapy within 3 months or 5 half-lives (whichever longer) before randomization.
- Use of systemic non-biologic psoriasis agents and/or any systemic immunosuppressants within 4 weeks before randomization, including but not limited to: apremilast, methotrexate, azathioprine, cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate, hydroxyurea, tacrolimus, oral/injectable corticosteroids, retinoids, calcitriol/analogs, psoralen, sulfasalazine, fumarates).
- Use of Lithium, antimalarials, or intramuscular gold preparations within 4 weeks before randomization.
- Use of any botanical agents for the treatment of psoriasis or other immune disorders within 4 weeks before randomization, including herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals.
- Received phototherapy within 4 weeks before randomization.
- Use of medicated shampoos and/or body washes within 2 weeks before randomization, including but not limited to products containing: corticosteroids, coal tar, >3% salicylic acid, vitamin D3 analogs.
- Use of any topical agents that may affect psoriasis symptoms within 2 weeks before randomization.
- Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) before randomization, OR current participation in other trial.
- Laboratory values meeting any of the following criteria during screening or before randomization:
- Liver: ALT/AST ≥3×ULN; total bilirubin >2×ULN
- Hematology: WBC <3.0×10⁹/L (3000/mm³); ANC <1.0×10⁹/L (1000/mm³); lymphocyte count <0.5×10⁹/L (500/mm³); platelets <100×10⁹/L (100,000/mm³); hemoglobin <9.0 g/dL (90 g/L)
- Renal: eGFR <60 mL/min/1.73m² (CKD-EPI equation)
- Pregnant or lactating women.
- Any condition deemed unsuitable by the investigator.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Fenglin Zhuo, 15910895068, 770972657@qq.com
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Jianzhong Zhang, 18001315877, rmzjz@126.com
Cheng Zhou, 18910291182, rmpkzc@163.com
- Not yet recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei
Xinsuo Duan, 15633142680, 15633142680@163.com
Xiaoqin Zhu, 15633142669, 15633142669@163.com
- Not yet recruiting
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang
Liming Wu, 13750837205, 18957118053@163.com
- Not yet recruiting
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong
Furen Zhang, 13608921718, sdpysll@163.com
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Guoqiang Zhang, 18633888122, zgq810328@sina.com
Chunhua Zhou, 18633881377, zhouchunhua80@126.com
- Not yet recruiting
Shiyan People's Hospital
Shiyan, Hubei
Zudong Meng, 0719-8637553, 1970547910@qq.com
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
Shuping Guo, 18503519388, gsp6688@sina.com
- Not yet recruiting
The First Affliated Hospital of Wenzhou Medical University
Wenzhou, Zhengjiang
Zhiming Li, 15988718867, zhi-mingli@163.com
Huafang Chen, 13857727395, Chenhuafang2011@126.com
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
Xi’an, Shanxi
Songmei Geng, 13060423612, gengsongmei73@163.com
Hui Guo, 13572824106, guohuihappy97@163.com
- Not yet recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang
Lunfei Liu, 13858036789, liulunfei_zeyy@163.com
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis
" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks.
Part 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment.
The resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.
- Conditions
- Plaque Psoriasis
- Being tested
- CS32582 capsule（low dose） or matched placebo, CS32582 capsule（high dose） or matched placebo, CS32582 capsule（low dose）, CS32582 capsule（medium dose）, CS32582 capsule（high dose）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS32582 capsule（low dose） or matched placeboDrug
CS32582 capsule（low dose） or matched placebo，4 weeks
CS32582 capsule（high dose） or matched placeboDrug
CS32582 capsule（high dose） or matched placebo，4 weeks
CS32582 capsule（low dose）Drug
CS32582 capsule（low dose），12 weeks
CS32582 capsule（medium dose）Drug
CS32582 capsule（medium dose），12 weeks
CS32582 capsule（high dose）Drug
CS32582 capsule（high dose），12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part 1：Low dose CS32582 | Experimental | The patient received low-dose CS32582 capsules BID or placebo for 4 weeks Receives: Drug: CS32582 capsule（low dose） or matched placebo |
| Part 1：Hgh dose CS32582 | Experimental | The patient received high-dose CS32582 capsules BID or placebo for 4 weeks Receives: Drug: CS32582 capsule（high dose） or matched placebo |
| Part 2：Low dose CS32582 | Experimental | The patient received low-dose CS32582 capsules BID or placebo for 12 weeks Receives: Drug: CS32582 capsule（low dose） |
| Part 2：Medium dose CS32582 | Experimental | The patient received medium-dose CS32582 capsules BID or placebo for 12 weeks Receives: Drug: CS32582 capsule（medium dose） |
| Part 2：High dose CS32582 | Experimental | The patient received high-dose CS32582 capsules BID or placebo for 12 weeks Receives: Drug: CS32582 capsule（high dose） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1：Incidence and Severity of Adverse Events (AEs)
Measured: 5 weeks
Part 2：Proportion of patients achieved Psoriasis Area Severity Index (PASI) 75 at Week 12
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity.
PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.
Measured: Week 12
Secondary outcomes (15)
Part 1： Changes from baseline in PASI
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity.
Measured: Week 4
Part 1： Changes from baseline in sPGA
Static Physician's Global Assessment (sPGA) is an average assessment of all psoriatic lesions, with scores ranging from 0 (indicating clear) to 5 (indicating severe).
Measured: Week 4
Part 1： Changes from baseline in BSA
Body Surface Area (BSA) scores range from 0% (indicating absence of lesions) to 100% (indicating total body surface involvement), with higher scores correlating to greater disease severity.
Measured: Week 4
Part 1： Changes from baseline in DLQI
Dermatology Life Quality Index（DLQI) total score ranges from 0 (indicating no impairment in quality of life) to 30 (indicating maximum impairment in quality of life).
Measured: Week 4
Part 1：Proportion of patients achieving PASI 50/75/90/100
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 50 is defined as the proportion of patients achieving ≥50% reduction in PASI score from baseline. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.PASI 90 is defined as the proportion of patients achieving ≥90% reduction in PASI score from baseline.PASI 100 is defined as the proportion of patients achieving ≥100% reduction in PASI score from baseline.
Measured: Week 4
Part 2：Incidence and Severity of Adverse Events (AEs)
Measured: 16 weeks
Part 2：Proportion of patients achieving PASI 75
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.
Measured: Week 4 and 8
Part 2：Proportion of patients achieving PASI 50/90/100
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 50 is defined as the proportion of patients achieving ≥50% reduction in PASI score from baseline. PASI 90 is defined as the proportion of patients achieving ≥90% reduction in PASI score from baseline.PASI 100 is defined as the proportion of patients achieving ≥100% reduction in PASI score from baseline.
Measured: Week 4，8 and 12
Part 2：Proportion of patients achieving: (a) sPGA score of 0 or 1 with ≥2-point reduction from baseline (b) sPGA clearance (score 0) (c) Disease remission
Measured: Week 4，8 and 12
Part 2： Changes from baseline in PASI
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity.
Measured: Week 4，8 and 12
Part 2： Changes from baseline in BSA
Body Surface Area (BSA) scores range from 0% (indicating absence of lesions) to 100% (indicating total body surface involvement), with higher scores correlating to greater disease severity.
Measured: Week 4，8 and 12
Part 2： Changes from baseline in sPGA
Static Physician's Global Assessment (sPGA) is an average assessment of all psoriatic lesions, with scores ranging from 0 (indicating clear) to 5 (indicating severe).
Measured: Week 4，8 and 12
Part 2： Changes from baseline in DLQI
Dermatology Life Quality Index（DLQI) total score ranges from 0 (indicating no impairment in quality of life) to 30 (indicating maximum impairment in quality of life).
Measured: Week 4，8 and 12
Pharmacokinetic parameters - Area Under the Curve(AUC)
Measured: Day 1~Day 85
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Measured: Day 1~Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start8 Sep 2025
- Primary completion18 Sep 2027 (estimated)
- Study completion18 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Chipscreen Biosciences, Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129382
- Sponsor's protocol ID
- CS32582-201
- Acronym
- MECAP
- Status last verified
- Nov 2026
- First submitted
- 11 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07129382
- Acronym / sponsor ID
- MECAP / CS32582-201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 18 Sep 2027 (estimated)
- Study completion
- 18 Sep 2027 (estimated)
- First posted
- 19 Aug 2025 (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 study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks.
Part 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment.
The resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1：Low dose CS32582 | Experimental | Drug: CS32582 capsule（low dose） or matched placeboThe patient received low-dose CS32582 capsules BID or placebo for 4 weeks |
| Part 1：Hgh dose CS32582 | Experimental | Drug: CS32582 capsule（high dose） or matched placeboThe patient received high-dose CS32582 capsules BID or placebo for 4 weeks |
| Part 2：Low dose CS32582 | Experimental | Drug: CS32582 capsule（low dose）The patient received low-dose CS32582 capsules BID or placebo for 12 weeks |
| Part 2：Medium dose CS32582 | Experimental | Drug: CS32582 capsule（medium dose）The patient received medium-dose CS32582 capsules BID or placebo for 12 weeks |
| Part 2：High dose CS32582 | Experimental | Drug: CS32582 capsule（high dose）The patient received high-dose CS32582 capsules BID or placebo for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily sign the informed consent form (ICF) after fully understanding the trial.
- Age 18-70 years (inclusive) at consent, any gender
- Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening.
- Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed).
- Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%;
Key exclusion criteria (43 listed)
- Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) .
- Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment.
- Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.
- History of severe drug allergies.
- Major surgery within 2 months before randomization or planned during the study.
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 |
|---|---|---|
| CS32582 capsule（low dose） or matched placeboCS32582 capsule（low dose） or matched placebo，4 weeks | Drug | Part 1：Low dose CS32582 |
| CS32582 capsule（high dose） or matched placeboCS32582 capsule（high dose） or matched placebo，4 weeks | Drug | Part 1：Hgh dose CS32582 |
| CS32582 capsule（low dose）CS32582 capsule（low dose），12 weeks | Drug | Part 2：Low dose CS32582 |
| CS32582 capsule（medium dose）CS32582 capsule（medium dose），12 weeks | Drug | Part 2：Medium dose CS32582 |
| CS32582 capsule（high dose）CS32582 capsule（high dose），12 weeks | Drug | Part 2：High dose CS32582 |
Primary outcome
Part 1：Incidence and Severity of Adverse Events (AEs)
Time frame: 5 weeks
Part 2：Proportion of patients achieved Psoriasis Area Severity Index (PASI) 75 at Week 12
Time frame: Week 12
Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.
15 secondary outcomes
Part 1： Changes from baseline in PASI
Time frame: Week 4
Part 1： Changes from baseline in sPGA
Time frame: Week 4
Part 1： Changes from baseline in BSA
Time frame: Week 4
Part 1： Changes from baseline in DLQI
Time frame: Week 4
Part 1：Proportion of patients achieving PASI 50/75/90/100
Time frame: Week 4
Part 2：Incidence and Severity of Adverse Events (AEs)
Time frame: 16 weeks
Part 2：Proportion of patients achieving PASI 75
Time frame: Week 4 and 8
Part 2：Proportion of patients achieving PASI 50/90/100
Time frame: Week 4，8 and 12
Part 2：Proportion of patients achieving: (a) sPGA score of 0 or 1 with ≥2-point reduction from baseline (b) sPGA clearance (score 0) (c) Disease remission
Time frame: Week 4，8 and 12
Part 2： Changes from baseline in PASI
Time frame: Week 4，8 and 12
Part 2： Changes from baseline in BSA
Time frame: Week 4，8 and 12
Part 2： Changes from baseline in sPGA
Time frame: Week 4，8 and 12
Part 2： Changes from baseline in DLQI
Time frame: Week 4，8 and 12
Pharmacokinetic parameters - Area Under the Curve(AUC)
Time frame: Day 1~Day 85
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Time frame: Day 1~Day 85
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CS32582 capsule（low dose）, CS32582 capsule（medium dose） and CS32582 capsule（high dose） in people with Plaque Psoriasis, run by Chipscreen Biosciences, Ltd. at 11 sites 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 7 inclusion and 43 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianzhong Zhang (18001315877, rmzjz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1：Incidence and Severity of Adverse Events (AEs) (time frame: 5 weeks). 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?
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 5 Nov 2026.