Premature Ovarian InsufficiencyPhase 1/2NCT07775391
Phase Ⅰ/Ⅱa Trial Evaluating Intravenous hUC-MSCs Injection for Safety, Tolerability and Efficacy in Patients With POI
A Phase 1/2 study testing hUC-MSCs Injection (Phase I) and hUC-MSCs Injection (Phase IIa) in people with Premature Ovarian Insufficiency, run by Shenzhen Wingor Biotechnology Co., Ltd. at 1 site in China.
Trial summary
A Phase I/IIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- hUC-MSCs Injection (Phase I) and hUC-MSCs Injection (Phase IIa)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2026to 2 Aug 2029
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 40 years at the time of signing the informed consent form (exclusive of the boundary values);
- Meet the diagnostic criteria specified in the Expert Consensus on Clinical Diagnosis and Treatment of Premature Ovarian Insufficiency (2023 Edition): oligomenorrhea (menstrual cycle longer than 35 days) or amenorrhea for more than 4 months, with basal serum follicle-stimulating hormone (FSH) > 25 U/L (tested on Days 2-4 of the menstrual cycle or during amenorrhea, at least twice with an interval of ≥4 weeks);
- Satisfy one of the following two criteria:
- Total number of antral follicles (AFC) with a diameter of 2-10 mm in bilateral ovaries < 5;
- Serum anti-Müllerian hormone (AMH) ≤ 7.85 pmol/L (equivalent to 1.1 ng/mL);
- Have received standardized hormone replacement therapy (HRT) at a stable dose for ≥3 months prior to drug administration with stable hormone levels, and maintain stable HRT per medical advice throughout the trial (within 24 weeks after enrollment);
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- Have no fertility requirements;
- Agree to use effective contraceptive measures throughout the trial period (such as complete abstinence, condoms, cervical caps plus spermicides, intrauterine devices, etc.);
- Negative serum β-hCG test result during the screening period (to rule out pregnancy);
- Fully understand the trial information and sign the informed consent form.
Who cannot join
- Subjects with primary amenorrhea;
- Subjects with thyroid disorders (hypothyroidism/hyperthyroidism or thyroid malignant tumors) or resistant ovary syndrome (ROS);
- Subjects with abnormal female karyotypes (e.g., Turner syndrome, Fragile X syndrome);
- Positive serology tests (HBV antibody, HCV antibody, HIV antibody, syphilis). Exceptions: HBV carriers, patients with stable HBV after drug treatment (HBV DNA titer ≤500 IU/mL or copies <1000 copies/mL), and patients with cured HCV (negative HCV RNA test) may be enrolled if deemed eligible by the investigator;
- Subjects receiving or planning to use the following medications during the trial: oral or systemic corticosteroids, danazol, anticoagulants, Chinese herbal medicines or botanical supplements that may affect hormone levels or ovarian function;
- History of hypersensitivity to human serum albumin;
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- Pregnant or breastfeeding subjects;
- Participation in another clinical trial within the past 3 months, or receipt of other cell therapies (excluding blood transfusion);
- History of malignant tumors;
- Subjects with contraindications or cautions for estrogen use, including known or suspected breast cancer, endometrial cancer, other known or suspected sex hormone-dependent malignancies, active venous or arterial thromboembolic diseases within the last 6 months, undiagnosed abnormal genital bleeding, severe hepatic or renal insufficiency [serum aspartate aminotransferase (AST) >3×ULN, serum alanine aminotransferase (ALT) >3×ULN, estimated glomerular filtration rate (eGFR) <60 mL/min], etc.;
- Uncontrolled diabetes, hypertension (>150/100 mmHg), heart disease, etc.;
- Any other conditions judged by the investigator to render the subject unsuitable for participation in this study.
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, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Qi Yu, Prof., +86 10 6915 8621, yuqimd@163.com
About this study
Official title: Phase Ⅰ/Ⅱa Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Injection of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in Patients With Premature Ovarian Insufficiency (POI)
A Phase I/IIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI).
The primary objective of the Phase I dose-escalation stage is to assess the safety and tolerability of intravenous infusion of hUC-MSCs injection for the treatment of POI, and to determine the recommended phase II dose (RP2D) for the Phase IIa clinical trial.
The primary objective of the Phase IIa dose-expansion stage is to evaluate the efficacy of intravenous infusion of hUC-MSCs injection in POI treatment, and to generate data to support pivotal/confirmatory clinical trials.
Read the detailed description
Premature ovarian insufficiency (POI) is defined as ovarian dysfunction occurring in women before the age of 40, which is mainly characterized by menstrual abnormalities (amenorrhea, oligomenorrhea or polymenorrhea), elevated gonadotropin levels (FSH > 25 U/L), and fluctuating decline in estrogen levels. The incidence of POI is age-specific: 1 in 250 women develops POI before 35 years of age, and 1 in 100 women develops POI before 40 years of age. The incidence rate of POI in China is 2.8%, showing an upward trend year by year with a younger onset age.
hormone replacement therapy (HRT) relieves symptoms caused by low estrogen through estrogen supplementation. Sequential estrogen-progestogen therapy is recommended for POI patients with an intact uterus. Since patients with POI require long-term HRT, natural or nearly natural estrogens and progestogens can be selected to minimize adverse effects on the mammary gland, metabolism, cardiovascular system and other systems. Nevertheless, HRT still increases the risks of breast cancer, heart disease and stroke.
Studies have demonstrated that mesenchymal stem cells can home to ovarian stroma, regulate the balance of Th1/Th2 cytokines and the expression of endometrial natural killer cells, alleviate inflammatory responses, inhibit apoptosis of ovarian granulosa cells and reduce ovarian interstitial fibrosis, thereby improving the ovarian microenvironment. Meanwhile, these cells can secrete growth factors including VEGF, IGF-1 and HGF, promote proliferation of various ovarian cells and angiogenesis, repair ovarian structure and restore ovarian ovarian function. This study aims to evaluate the safety, tolerability and efficacy of intravenously administered hUC-MSCs in the treatment of patients with POI.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- hUC-MSCs Injection (Phase I), hUC-MSCs Injection (Phase IIa), Placebo
- Keywords
- hUC-MSCs, POI, Premature Ovarian Insufficiency
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUC-MSCs Injection (Phase I)Drug
Also called hUC-MSCs
hUC-MSCs Injection, administered via intravenous infusion as a single dose on D0.
hUC-MSCs Injection (Phase IIa)Drug
Also called hUC-MSCs
hUC-MSCs Injection, 3 infusions in total, dosing interval ≥7 days.
PlaceboDrug
3 infusions in total, dosing interval ≥7 days
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Dose Cohort 1 | Experimental | Human Umbilical Cord Mesenchymal Stem Cells Injection Receives: Drug: hUC-MSCs Injection (Phase I) |
| Phase I, Dose Cohort 2 | Experimental | Human Umbilical Cord Mesenchymal Stem Cells Injection Receives: Drug: hUC-MSCs Injection (Phase I) |
| Phase I, Dose Cohort 3 | Experimental | Human Umbilical Cord Mesenchymal Stem Cells Injection Receives: Drug: hUC-MSCs Injection (Phase I) |
| Phase IIa, Medium-Dose Cohort | Experimental | Human Umbilical Cord Mesenchymal Stem Cells Injection Receives: Drug: hUC-MSCs Injection (Phase IIa) |
| Phase IIa, High-Dose Cohort | Experimental | Human Umbilical Cord Mesenchymal Stem Cells Injection Receives: Drug: hUC-MSCs Injection (Phase IIa) |
| Phase IIa, Placebo Cohort | Placebo comparator | Multiple Electrolytes Injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I : Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
In this Phase I stage, safety is the primary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
Measured: 48 weeks
Phase II ：FSH
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels at Week 24 post-treatment.
Measured: at Week 24 post-treatment
Phase II ：E2
To evaluate the changes from baseline in serum festradiol (E2) levels at Week 24 post-treatment.
Measured: at Week 24 post-treatment
Phase II ：AMH
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels at Week 24 post-treatment.
Measured: at Week 24 post-treatment
Secondary outcomes (8)
Phase I: FSH
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels.
Measured: 48 weeks
Phase I ：E2
To evaluate the changes from baseline in serum estradiol (E2) levels
Measured: 48 weeks
Phase I : AMH
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels.
Measured: 48 weeks
Phase II: Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
In this Phase II stage, safety is the secondary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
Measured: 48 weeks
Phase I/II: AFC
Changes from baseline in antral follicle count (AFC) by transvaginal ultrasound.
Measured: 48 weeks
Phase I/II: endometrial thickness
Changes from baseline in endometrial thickness measured by transvaginal ultrasound.
Measured: 48 weeks
Phase I/II: menstrual recovery status
Menstrual recovery status will be assessed via patient inquiry at each visit.
Measured: 48 weeks
Phase I/II:Modified Kupperman Index
To evaluate the changes in the Modified Kupperman Index from baseline across all post-baseline follow-up visits.
Modified Kupperman Index will be assessed through physician interview.The total score ranges from 0 to 63 points. Total score stratification: >30 points indicates severe symptoms, 16-30 points moderate symptoms, 6-15 points mild symptoms, and <6 points normal status.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start3 Aug 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion2 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: This is an open-label, dose-escalation trial consisting of three sequential ascending-dose cohorts enrolling 3 subjects per cohort (total 9 subjects). Extra 3 subjects may be added to the highest-dose cohort to assess the maximum tolerated dose (MTD). Each subject receives one single intravenous infusion on Day 0. Phase IIa: This randomized, double-blind, placebo-controlled trial includes two active dose groups and one placebo group with a 2:1 randomization ratio of combined active arms to placebo. Each active group plans 20 subjects and the placebo group plans 10 subjects, all receiving three administrations of study treatment, with a total intended enrollment of 50 subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Wingor Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775391
- Sponsor's protocol ID
- WG108-POI-I/IIa
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅰ/Ⅱa Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Injection of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in Patients With Premature Ovarian Insufficiency (POI)
- ClinicalTrials.gov ID
- NCT07775391
- Acronym / sponsor ID
- WG108-POI-I/IIa
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- hUC-MSCs, POI, Premature Ovarian Insufficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Shenzhen Wingor Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 2 Aug 2029 (estimated)
- First posted
- 20 Aug 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.
A Phase I/IIa clinical study evaluating the safety, tolerability and efficacy of intravenously administered human umbilical cord mesenchymal stem cell (hUC-MSCs) injection in patients with premature ovarian insufficiency (POI).
The primary objective of the Phase I dose-escalation stage is to assess the safety and tolerability of intravenous infusion of hUC-MSCs injection for the treatment of POI, and to determine the recommended phase II dose (RP2D) for the Phase IIa clinical trial.
The primary objective of the Phase IIa dose-expansion stage is to evaluate the efficacy of intravenous infusion of hUC-MSCs injection in POI treatment, and to generate data to support pivotal/confirmatory clinical trials.
Detailed description
Premature ovarian insufficiency (POI) is defined as ovarian dysfunction occurring in women before the age of 40, which is mainly characterized by menstrual abnormalities (amenorrhea, oligomenorrhea or polymenorrhea), elevated gonadotropin levels (FSH > 25 U/L), and fluctuating decline in estrogen levels. The incidence of POI is age-specific: 1 in 250 women develops POI before 35 years of age, and 1 in 100 women develops POI before 40 years of age. The incidence rate of POI in China is 2.8%, showing an upward trend year by year with a younger onset age.
hormone replacement therapy (HRT) relieves symptoms caused by low estrogen through estrogen supplementation. Sequential estrogen-progestogen therapy is recommended for POI patients with an intact uterus. Since patients with POI require long-term HRT, natural or nearly natural estrogens and progestogens can be selected to minimize adverse effects on the mammary gland, metabolism, cardiovascular system and other systems. Nevertheless, HRT still increases the risks of breast cancer, heart disease and stroke.
Studies have demonstrated that mesenchymal stem cells can home to ovarian stroma, regulate the balance of Th1/Th2 cytokines and the expression of endometrial natural killer cells, alleviate inflammatory responses, inhibit apoptosis of ovarian granulosa cells and reduce ovarian interstitial fibrosis, thereby improving the ovarian microenvironment. Meanwhile, these cells can secrete growth factors including VEGF, IGF-1 and HGF, promote proliferation of various ovarian cells and angiogenesis, repair ovarian structure and restore ovarian ovarian function. This study aims to evaluate the safety, tolerability and efficacy of intravenously administered hUC-MSCs in the treatment of patients with POI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Phase 1: This is an open-label, dose-escalation trial consisting of three sequential ascending-dose cohorts enrolling 3 subjects per cohort (total 9 subjects). Extra 3 subjects may be added to the highest-dose cohort to assess the maximum tolerated dose (MTD). Each subject receives one single intravenous infusion on Day 0. Phase IIa: This randomized, double-blind, placebo-controlled trial includes two active dose groups and one placebo group with a 2:1 randomization ratio of combined active arms to placebo. Each active group plans 20 subjects and the placebo group plans 10 subjects, all receiving three administrations of study treatment, with a total intended enrollment of 50 subjects.
| Arm | Type | Receives |
|---|---|---|
| Phase I, Dose Cohort 1 | Experimental | Drug: hUC-MSCs Injection (Phase I)Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Phase I, Dose Cohort 2 | Experimental | Drug: hUC-MSCs Injection (Phase I)Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Phase I, Dose Cohort 3 | Experimental | Drug: hUC-MSCs Injection (Phase I)Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Phase IIa, Medium-Dose Cohort | Experimental | Drug: hUC-MSCs Injection (Phase IIa)Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Phase IIa, High-Dose Cohort | Experimental | Drug: hUC-MSCs Injection (Phase IIa)Human Umbilical Cord Mesenchymal Stem Cells Injection |
| Phase IIa, Placebo Cohort | Placebo comparator | Drug: PlaceboMultiple Electrolytes Injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged 18 to 40 years at the time of signing the informed consent form (exclusive of the boundary values);
- Meet the diagnostic criteria specified in the Expert Consensus on Clinical Diagnosis and Treatment of Premature Ovarian Insufficiency (2023 Edition): oligomenorrhea (menstrual cycle longer than 35 days) or amenorrhea for more than 4 months, with basal serum follicle-stimulating hormone (FSH) > 25 U/L (tested on Days 2-4 of the menstrual cycle or during amenorrhea, at least twice with an interval of ≥4 weeks);
- Satisfy one of the following two criteria:
- Have received standardized hormone replacement therapy (HRT) at a stable dose for ≥3 months prior to drug administration with stable hormone levels, and maintain stable HRT per medical advice throughout the trial (within 24 weeks after enrollment);
- Have no fertility requirements;
Key exclusion criteria (12 listed)
- Subjects with primary amenorrhea;
- Subjects with thyroid disorders (hypothyroidism/hyperthyroidism or thyroid malignant tumors) or resistant ovary syndrome (ROS);
- Subjects with abnormal female karyotypes (e.g., Turner syndrome, Fragile X syndrome);
- Positive serology tests (HBV antibody, HCV antibody, HIV antibody, syphilis). Exceptions: HBV carriers, patients with stable HBV after drug treatment (HBV DNA titer ≤500 IU/mL or copies <1000 copies/mL), and patients with cured HCV (negative HCV RNA test) may be enrolled if deemed eligible by the investigator;
- Subjects receiving or planning to use the following medications during the trial: oral or systemic corticosteroids, danazol, anticoagulants, Chinese herbal medicines or botanical supplements that may affect hormone levels or ovarian function;
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 |
|---|---|---|
| hUC-MSCs Injection (Phase I)Also: hUC-MSCshUC-MSCs Injection, administered via intravenous infusion as a single dose on D0. | Drug | Phase I, Dose Cohort 1, Phase I, Dose Cohort 2, Phase I, Dose Cohort 3 |
| hUC-MSCs Injection (Phase IIa)Also: hUC-MSCshUC-MSCs Injection, 3 infusions in total, dosing interval ≥7 days. | Drug | Phase IIa, High-Dose Cohort, Phase IIa, Medium-Dose Cohort |
| Placebo3 infusions in total, dosing interval ≥7 days | Drug | Phase IIa, Placebo Cohort |
Primary outcome
Phase I : Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
Time frame: 48 weeks
In this Phase I stage, safety is the primary endpoint. Types, frequencies, severities and causal relationships of all adverse events (AEs) and serious adverse events (SAEs) occurring from the first administration of study drug to the end of safety follow-up (48 weeks), assessed in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0; together with the proportion of adverse events judged by the investigator to be related to the study drug.
Phase II ：FSH
Time frame: at Week 24 post-treatment
To evaluate the changes from baseline in serum follicle-stimulating hormone (FSH) levels at Week 24 post-treatment.
Phase II ：E2
Time frame: at Week 24 post-treatment
To evaluate the changes from baseline in serum festradiol (E2) levels at Week 24 post-treatment.
Phase II ：AMH
Time frame: at Week 24 post-treatment
To evaluate the changes from baseline in serum anti-Müllerian hormone (AMH) levels at Week 24 post-treatment.
8 secondary outcomes
Phase I: FSH
Time frame: 48 weeks
Phase I ：E2
Time frame: 48 weeks
Phase I : AMH
Time frame: 48 weeks
Phase II: Incidence and number of subjects with treatment-emergent adverse events and serious adverse events.
Time frame: 48 weeks
Phase I/II: AFC
Time frame: 48 weeks
Phase I/II: endometrial thickness
Time frame: 48 weeks
Phase I/II: menstrual recovery status
Time frame: 48 weeks
Phase I/II:Modified Kupperman Index
Time frame: 48 weeks
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 20 Aug 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.
1 site 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 hUC-MSCs Injection (Phase I) and hUC-MSCs Injection (Phase IIa) in people with Premature Ovarian Insufficiency, run by Shenzhen Wingor Biotechnology Co., 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 10 inclusion and 12 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 20 Aug 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. 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 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 Xiaohong Wang,MD (+86 755 6683 5786, xiaohong@wingor.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I : Incidence and number of subjects with treatment-emergent adverse events and serious adverse events. (time frame: 48 weeks). The study lists 4 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 20 Aug 2026.