Atopic Dermatitis (AD)Phase 1/2NCT07182864
MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis
A Phase 1/2 study testing MH004 0.1% Ointment, MH004 0.3% Ointment and MH004 1.0% Ointment in people with Atopic Dermatitis (AD), run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial summary
This is a Phase I/II Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- MH004 0.1% Ointment, MH004 0.3% Ointment and MH004 1.0% Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2022to 8 Oct 2022
- Phase
- Phase 1/2
- 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 12 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Phase I: Adults, age 18 - 70 years old, inclusive. Phase II: Adolescents aged ≥ 12 to 17 years, inclusive. Adults, age 18 - 70 years old, inclusive, at time of screening.
- Phase II: clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 6 months prior to Day 1.
- Phase II: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
- -
Who cannot join
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Concurrent conditions and history of other diseases:
- Immunocompromised.
- Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before Baseline.
- Active acute bacterial, fungal, or viral skin infection within 1 week before Baseline.
- Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
Show all 15Show fewer
- Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
- Other types of eczema.
- Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
- Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
- Previously received Janus kinase (JAK) inhibitors, systemic or topical.
- Ultraviolet light therapy or prolonged exposure to UV radiation within 2 weeks before dosing.
- Liver function tests: AST or ALT ≥ 2 × ULN; alkaline phosphatase and/or bilirubin > 1.5 × ULN.
- Pregnant or lactating participants, or those considering pregnancy.
- Alcohol or drug abuse. -
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: Phase I/II Study of MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis
This is a Phase I/II Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis.
Read the detailed description
The study includes 2 parts: The first part (Phase I) is the first-in-human trial of MH004, consisting of a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy volunteers. The second part is a multi-center, randomized, double-Blind, vehicle-controlled phase II study to evaluate the safety, tolerability and PK of MH004 Ointment for AD participants, using defined concentrations of the topical cream based on the PK and safety data in healthy volunteers in Phase I.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- MH004 0.1% Ointment, MH004 0.3% Ointment, MH004 1.0% Ointment, MH004 3.0% Ointment, Vehicle Ointment
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MH004 0.1% OintmentDrug
MH004 0.1% ointment applied topically to the affected area as a thin film.
MH004 0.3% OintmentDrug
MH004 0.3% ointment applied topically to the affected area as a thin film.
MH004 1.0% OintmentDrug
MH004 1.0% ointment applied topically to the affected area as a thin film.
MH004 3.0% OintmentDrug
MH004 3.0% ointment applied topically to the affected area as a thin film.
Vehicle OintmentDrug
Matching vehicle ointment applied topically to the affected area as a thin film.
| Study group | Role | What they receive |
|---|---|---|
| Phase I. MH004 (0.1%) in healthy volunteers SAD and MAD | Experimental | SAD and MAD Receives: Drug: MH004 0.1% Ointment |
| Phase I: MH004 (0.3%) in healthy volunteers SAD and MAD | Experimental | SAD and MAD Receives: Drug: MH004 0.3% Ointment |
| Phase I: MH004 (1.0%) in healthy volunteers SAD and MAD | Experimental | SAD and MAD Receives: Drug: MH004 1.0% Ointment |
| Phase I: MH004 (3.0%) in healthy volunteers SAD and MAD | Experimental | SAD and MAD Receives: Drug: MH004 3.0% Ointment |
| Phase II. MH004 (0.1%) in Atopic Dermatitis | Experimental | 28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis Receives: Drug: MH004 0.1% Ointment |
| Phase II. MH004 (0.3%) in Atopic Dermatitis | Experimental | 28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis Receives: Drug: MH004 0.3% Ointment |
| Experimental: Phase II. MH004 (1.0%) in Atopic Dermatitis | Experimental | 28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis Receives: Drug: MH004 1.0% Ointment |
| Experimental: Phase II. MH004 (3.0%) in Atopic Dermatitis | Experimental | 28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis Receives: Drug: MH004 3.0% Ointment |
| Phase I. Vehicle Ointment in healthy volunteers SAD and MAD | Placebo comparator | SAD and MAD Receives: Drug: Vehicle Ointment |
| Phase II. Vehicle Ointment in Atopic Dermatitis | Placebo comparator | 28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis Receives: Drug: Vehicle Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability)
Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 The incidence, nature, and severity of AEs/SAEs including relationship to study treatment from MAD initial study drug administration time of randomization until Day 14 for MAD participants. The incidence, nature, and severity of AEs/SAEs leading to treatment discontinuation from MAD initial study drug administration time of randomisation until Day 7 for MAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from initial study drug administration time of randomisation until Day 7 for SAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.
Measured: 1 year
Phase II: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With MH004 Ointment
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline and week 4.
Secondary outcomes (6)
Phase I: Characterization of Pharmacokinetics (Cmax) of MH004 Ointment in Healthy Volunteers or Participants With Mild to Moderate Atopic Dermatitis
Maximum drug concentration (Cmax)
Measured: Up to 6 Months
Phase II: Mean Percentage Change From Baseline in EASI Score at Week 2
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
Measured: Baseline, Week 2
Percentage of Participants Who Achieve a ≥ 50% or ≥ 75% Improvement From Baseline in EASI (EASI-50 or EASI-75) at Weeks 4
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD).
Measured: Baseline, Week 4
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 4
IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.
Measured: Baseline, Week 4
Mean Change From Baseline in the Scoring in Atopic Dermatitis at Week 4
SCORAD is a clinical tool used to assess the severity (range/severity) and subjective signs/symptoms (such as itching/insomnia) of AD. The degree of the lesion was scored using the nine-point method. The severity was determined by grading the severity of six signs (erythema, edema, exudation/scabbing, epidermal exfoliation, lichenification and skin dryness) on a 0-3 subscale. The assessment of each physical sign was scored at the most representative lesion sites. Subjective symptoms were scored using the Visual Analogue Scale (VAS), with 0= no pruritus (or insomnia), and 10= the most severe pruritus (or insomnia). The total score is the sum of 5+7x severity /2+VAS (Symptoms), and the SCORAD score ranges from 0 to 103 points. The higher the score, the more severe the AD.
Measured: Baseline, Week 4
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start6 Jan 2022
- Primary completion8 Sep 2022
- Study completion8 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Minghui Pharmaceutical (Hangzhou) LtdThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182864
- Sponsor's protocol ID
- MH004-CP002CN
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of MH004 Ointment in Healthy Adult Volunteers and Participants With Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07182864
- Acronym / sponsor ID
- MH004-CP002CN
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Oct 2022 (actual)
- First posted
- 19 Sep 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 is a Phase I/II Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis.
Detailed description
The study includes 2 parts: The first part (Phase I) is the first-in-human trial of MH004, consisting of a single ascending dose (SAD) study and a multiple ascending dose (MAD) study in healthy volunteers. The second part is a multi-center, randomized, double-Blind, vehicle-controlled phase II study to evaluate the safety, tolerability and PK of MH004 Ointment for AD participants, using defined concentrations of the topical cream based on the PK and safety data in healthy volunteers in Phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase I. MH004 (0.1%) in healthy volunteers SAD and MAD | Experimental | Drug: MH004 0.1% OintmentSAD and MAD |
| Phase I: MH004 (0.3%) in healthy volunteers SAD and MAD | Experimental | Drug: MH004 0.3% OintmentSAD and MAD |
| Phase I: MH004 (1.0%) in healthy volunteers SAD and MAD | Experimental | Drug: MH004 1.0% OintmentSAD and MAD |
| Phase I: MH004 (3.0%) in healthy volunteers SAD and MAD | Experimental | Drug: MH004 3.0% OintmentSAD and MAD |
| Phase II. MH004 (0.1%) in Atopic Dermatitis | Experimental | Drug: MH004 0.1% Ointment28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis |
| Phase II. MH004 (0.3%) in Atopic Dermatitis | Experimental | Drug: MH004 0.3% Ointment28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis |
| Experimental: Phase II. MH004 (1.0%) in Atopic Dermatitis | Experimental | Drug: MH004 1.0% Ointment28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis |
| Experimental: Phase II. MH004 (3.0%) in Atopic Dermatitis | Experimental | Drug: MH004 3.0% Ointment28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis |
| Phase I. Vehicle Ointment in healthy volunteers SAD and MAD | Placebo comparator | Drug: Vehicle OintmentSAD and MAD |
| Phase II. Vehicle Ointment in Atopic Dermatitis | Placebo comparator | Drug: Vehicle Ointment28-Day Repeated Dosing in Participants with Mild to Moderate Atopic Dermatitis |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Phase I: Adults, age 18 - 70 years old, inclusive. Phase II: Adolescents aged ≥ 12 to 17 years, inclusive. Adults, age 18 - 70 years old, inclusive, at time of screening.
- Phase II: clinical diagnosis of mild to moderate atopic dermatitis (AD) for at least 6 months prior to Day 1.
- Phase II: IGA 2 to 3, affected BSA 3% to 20% (excluding scalp) at the baseline visit.
- Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.
- -
Key exclusion criteria (15 listed)
- Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Concurrent conditions and history of other diseases:
- Clinically significant cardiac disease; new cerebral infarction within 6 months from dosing; malignancies within 5 years from dosing; low hemoglobin; severe renal disease on dialysis; liver disease.
- Systemic corticosteroids treated within 4 weeks before dosing; immunizations or sedating antihistamines treated within 4 weeks before dosing; other topical treatments for AD within 1 week before dosing.
- Previously received Janus kinase (JAK) inhibitors, systemic or topical.
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 |
|---|---|---|
| MH004 0.1% OintmentMH004 0.1% ointment applied topically to the affected area as a thin film. | Drug | Phase I. MH004 (0.1%) in healthy volunteers SAD and MAD, Phase II. MH004 (0.1%) in Atopic Dermatitis |
| MH004 0.3% OintmentMH004 0.3% ointment applied topically to the affected area as a thin film. | Drug | Phase I: MH004 (0.3%) in healthy volunteers SAD and MAD, Phase II. MH004 (0.3%) in Atopic Dermatitis |
| MH004 1.0% OintmentMH004 1.0% ointment applied topically to the affected area as a thin film. | Drug | Experimental: Phase II. MH004 (1.0%) in Atopic Dermatitis, Phase I: MH004 (1.0%) in healthy volunteers SAD and MAD |
| MH004 3.0% OintmentMH004 3.0% ointment applied topically to the affected area as a thin film. | Drug | Experimental: Phase II. MH004 (3.0%) in Atopic Dermatitis, Phase I: MH004 (3.0%) in healthy volunteers SAD and MAD |
| Vehicle OintmentMatching vehicle ointment applied topically to the affected area as a thin film. | Drug | Phase I. Vehicle Ointment in healthy volunteers SAD and MAD, Phase II. Vehicle Ointment in Atopic Dermatitis |
Primary outcome
Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 1 year
Assess incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 The incidence, nature, and severity of AEs/SAEs including relationship to study treatment from MAD initial study drug administration time of randomization until Day 14 for MAD participants. The incidence, nature, and severity of AEs/SAEs leading to treatment discontinuation from MAD initial study drug administration time of randomisation until Day 7 for MAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from initial study drug administration time of randomisation until Day 7 for SAD participants. Clinically significant changes in laboratory parameters, vital signs, 12-lead ECG, and other safety assessments from MAD initial study drug administration time of randomisation until Day 14 for MAD participants.
Phase II: Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With MH004 Ointment
Time frame: Baseline and week 4.
EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.
6 secondary outcomes
Phase I: Characterization of Pharmacokinetics (Cmax) of MH004 Ointment in Healthy Volunteers or Participants With Mild to Moderate Atopic Dermatitis
Time frame: Up to 6 Months
Phase II: Mean Percentage Change From Baseline in EASI Score at Week 2
Time frame: Baseline, Week 2
Percentage of Participants Who Achieve a ≥ 50% or ≥ 75% Improvement From Baseline in EASI (EASI-50 or EASI-75) at Weeks 4
Time frame: Baseline, Week 4
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 4
Time frame: Baseline, Week 4
Mean Change From Baseline in the Scoring in Atopic Dermatitis at Week 4
Time frame: Baseline, Week 4
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity
Time frame: Up to Week 24
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 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
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 1/2 study testing MH004 0.1% Ointment, MH004 0.3% Ointment and MH004 1.0% Ointment in people with Atopic Dermatitis (AD), run by Minghui Pharmaceutical (Hangzhou) 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 15 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 19 Sep 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 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?
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?
Phase I: Incidence and severity of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 1 year). 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 19 Sep 2025.