PsoriasisPhase 1NCT06376474
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage
A Phase 1 study testing Hemay005 in people with Psoriasis, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Hemay005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2024to 31 Dec 2025
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;
- 2. Adults of both sexes aged from 18 to 70 years old (both ends, based on written informed consent);
- 3. The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
- 4. chronic stable liver impairment (no clinically significant change in disease status as judged by the investigator to have occurred for at least 28 days (or up to 14 days for patients with moderate liver function) before taking the study drug) due to primary liver disease (e.g., autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc.); Patients were classified as grade A/mild (Child-Pugh score: 5-6) or grade B/moderate (Child-Pugh score: 7-9) according to the Child-Pugh classification within 72 hours before taking the study drug; Among them, the researchers used standard diagnosis and treatment methods, combined with the patient's past medical history, laboratory tests, liver biopsy or imaging examination and other documents to diagnose chronic liver function impairment, and then evaluated according to the Child-Pugh classification.
- 5. (Inquiry) patients who have a stable medication plan for the treatment of liver function impairment, complications, and other concomitant diseases for at least 28 days (or 14 days for patients with moderate liver function) before taking the study drug, and who do not need to adjust the medication (including the type, dose, or frequency of medication); Or those who do not use drugs;
- 6.In addition to liver function damage and complications, the investigators were in good physical condition according to medical history inquiry, vital signs, physical examination, laboratory tests (blood routine, urine routine, stool routine, blood biochemistry, coagulation function, blood pregnancy (only female), 12-lead electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, electroencephalogram, etc.), and no other clinically significant abnormalities.
Who cannot join
- 1. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical portosystemic shunt; Patients with suspected or confirmed liver cancer or other malignant tumors; Patients with hepatorenal syndrome; Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that seriously affect bile excretion; Patients with complications such as hepatic encephalopathy (according to Child-Pugh criteria), liver failure, esophageal and gastric varices bleeding, severe/advanced ascites or pleural effusion requiring puncture drainage and albumin supplementation, who were considered by the investigator to be unsuitable;
- 2. (Inquiry) In addition to the disease causing liver function impairment, patients with serious acute or chronic diseases of other important organs within 1 year before screening, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immune and other diseases, judged by the investigator to be not suitable for the trial;
- 3. (Inquiry) Any of the following occurred within 6 months prior to study entry: Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including sustained ventricular tachycardia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), Unstable angina pectoris, coronary artery/peripheral artery bypass grafting, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism;
- 4. (asking) a history of depression or suicidal tendencies;
- 5. (Inquiry) patients who had severe gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive system surgery within 3 months before screening, and the investigators thought that the absorption of drugs was affected;
- 6. (Inquiry) patients who lost blood or donated more than 400mL of blood within one month before screening, or received red blood cell transfusion;
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- 7. (Inquiry) Liver function fluctuation (e.g., active hepatitis), rapid deterioration (e.g., advanced ascites, fever, active gastrointestinal bleeding), CTCAE 5.0 common adverse event grade ≥ 2, ongoing arrhythmia, atrial fibrillation of any grade during screening;
- 8.The screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) >5 times the normal value; (b) neutrophil count <1.0×109/L; (c) hemoglobin (HGB) <90 g/L; (d) platelet level <50×109/L; (e) subjects with alpha-fetoprotein (AFP) >50 ng/mL and suspected hepatocellular carcinoma;
- 9. (Inquiry) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic condition (such as allergic to two or more drugs, foods or pollens), or known allergic to PDE4 inhibitors (such as apast, roflumilast, etc.);
- 10. (inquiry) those who had a history of drug abuse in the past 5 years or drug abuse in the past 3 years before screening;
- 11. Screen-positive for drug abuse (except those screen-positive for drug abuse due to concomitant medication);
- 12. Positive breath alcohol test (alcohol concentration >0mg/L);
- 13. (Inquiry) who consumed more than 14 units of alcohol per week in the 3 months before screening (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44 mL of 40% liquor or 147 mL of 12% wine), or who could not abstain from alcohol during the study;
- 14. (Inquiry) who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study;
- 15. (Inquiry) subjects who consumed excessive amounts of tea, coffee and/or caffeine-rich beverages (more than 8 cups, 1 cup =250 mL) per day in the previous 3 months;
- 16. Having one or more of the tests for hepatitis B, C, HIV and syphilis clinically significant;
- 17. (Inquiry) who participated in clinical trials of other drugs/devices within 3 months before screening and used the trial drugs/devices;
- 18. (Inquiry) who had received drugs with definite potential hepatotoxicity (such as acetaminophen, statins, azithromycin, dapsone, clarithromycin, fluconazole, ketoconazole, rifampicin, etc.) for 7 consecutive days or more within 3 months before screening;
- 19. (Inquiry) Use of any drugs (e.g., inductors-barbiturates, pioglitazone, carbamazepine, phenytoin, glucocorticoids) that induce or inhibit hepatic drug-metabolizing enzymes within 30 days before screening; Inhibitors: SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazole, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, isoniazid);
- 20. (Inquiry) who used prescription drugs, over-the-counter drugs, health supplements, herbal products or vaccines other than those used for liver function impairment and other concomitant diseases within 2 weeks before screening;
- 21. (Inquiry) any caffeine/xanthine/food or drink (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine/xanthine/may affect the absorption, distribution, metabolism, excretion of drug in the judgment of the investigator during the period from screening to day -1 of admission, or unable to stop the intake of the above food or drink during the trial;
- 22. (Asking) pregnant or lactating women, or subjects (including male subjects) who have plans to give birth or donate sperm or eggs from two weeks before the trial to six months after the last dose of drug, unwilling or not to take effective contraceptive measures;
- 23. (inquiry) those who are unable to eat or have swallowing difficulties, have special dietary requirements and/or cannot follow a uniform diet;
- 24. (inquiry) with a history of epileptic seizures;
- 25. (Inquiry) Those who cannot tolerate venipuncture and/or have a history of dizzy with blood and needles;
- 26. Subjects with other factors considered by the investigator to be ineligible for the trial.
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
Union Hospital of Tongji Medical College; Huazhong University of Science and Technology
Wuhan, Hubei
Weiyong Li, 027-85726685
About this study
Official title: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild, Moderate Liver Impairment and Normal Liver Function After a Single Oral Administration
The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
Read the detailed description
To evaluate the pharmacokinetics and safety of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
- Conditions
- Psoriasis
- Being tested
- Hemay005
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005Drug
Also called Hemay005 tablet
15mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1
| Study group | Role | What they receive |
|---|---|---|
| Mild liver damage group | Experimental | 15mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 Receives: Drug: Hemay005 |
| Moderate liver damage group | Experimental | 15mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 Receives: Drug: Hemay005 |
| Healthy subjects | Experimental | 15mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 Receives: Drug: Hemay005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-Day6
Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-Day6
Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-Day6
Relevant pharmacokinetic parameters，half-life (T1/2)
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-Day6
Relevant pharmacokinetic parameters，clearance (CL/F)
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-Day6
Relevant pharmacokinetic parameters，volume of distribution (Vz/F)
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-Day6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start28 Apr 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiyong Li, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376474
- Sponsor's protocol ID
- HM005PS1S06
- Status last verified
- Nov 2025
- First submitted
- 9 Apr 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild, Moderate Liver Impairment and Normal Liver Function After a Single Oral Administration
- ClinicalTrials.gov ID
- NCT06376474
- Acronym / sponsor ID
- HM005PS1S06
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2024 (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.
The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
Detailed description
To evaluate the pharmacokinetics and safety of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild liver damage group | Experimental | Drug: Hemay00515mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 |
| Moderate liver damage group | Experimental | Drug: Hemay00515mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 |
| Healthy subjects | Experimental | Drug: Hemay00515mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Fully understand the content, process and possible adverse reactions of the trial before the trial, and be able to complete the study and sign the informed consent according to the requirements of the trial protocol;
- 2. Adults of both sexes aged from 18 to 70 years old (both ends, based on written informed consent);
- 3. The body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
- 4. chronic stable liver impairment (no clinically significant change in disease status as judged by the investigator to have occurred for at least 28 days (or up to 14 days for patients with moderate liver function) before taking the study drug) due to primary liver disease (e.g., autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc.); Patients were classified as grade A/mild (Child-Pugh score: 5-6) or grade B/moderate (Child-Pugh score: 7-9) according to the Child-Pugh classification within 72 hours before taking the study drug; Among them, the researchers used standard diagnosis and treatment methods, combined with the patient's past medical history, laboratory tests, liver biopsy or imaging examination and other documents to diagnose chronic liver function impairment, and then evaluated according to the Child-Pugh classification.
- 5. (Inquiry) patients who have a stable medication plan for the treatment of liver function impairment, complications, and other concomitant diseases for at least 28 days (or 14 days for patients with moderate liver function) before taking the study drug, and who do not need to adjust the medication (including the type, dose, or frequency of medication); Or those who do not use drugs;
Key exclusion criteria (26 listed)
- 1. (Inquiry) The subject has any of the following conditions: previous liver transplantation; Severe portal hypertension or transsurgical portosystemic shunt; Patients with suspected or confirmed liver cancer or other malignant tumors; Patients with hepatorenal syndrome; Biliary cirrhosis, biliary obstruction, cholestatic liver disease and other diseases that seriously affect bile excretion; Patients with complications such as hepatic encephalopathy (according to Child-Pugh criteria), liver failure, esophageal and gastric varices bleeding, severe/advanced ascites or pleural effusion requiring puncture drainage and albumin supplementation, who were considered by the investigator to be unsuitable;
- 2. (Inquiry) In addition to the disease causing liver function impairment, patients with serious acute or chronic diseases of other important organs within 1 year before screening, including but not limited to neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, hematological, immune and other diseases, judged by the investigator to be not suitable for the trial;
- 3. (Inquiry) Any of the following occurred within 6 months prior to study entry: Myocardial infarction, Congenital long QT syndrome, Torsades de pointes (including sustained ventricular tachycardia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), Unstable angina pectoris, coronary artery/peripheral artery bypass grafting, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism;
- 4. (asking) a history of depression or suicidal tendencies;
- 5. (Inquiry) patients who had severe gastrointestinal diseases (except secondary gastrointestinal diseases caused by hepatitis) or had digestive system surgery within 3 months before screening, and the investigators thought that the absorption of drugs was affected;
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 |
|---|---|---|
| Hemay005Also: Hemay005 tablet15mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 | Drug | Healthy subjects, Mild liver damage group, Moderate liver damage group |
Primary outcome
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，half-life (T1/2)
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，clearance (CL/F)
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，volume of distribution (Vz/F)
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
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 4 Dec 2025.
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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.
Weiyong Li principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Hemay005 in people with Psoriasis, run by Ganzhou Hemay Pharmaceutical 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 6 inclusion and 26 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 4 Dec 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. 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?
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 Zimeng Wang (022-24929667, wangzimeng@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） (time frame: Day1-Day6). The study lists 6 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 4 Dec 2025.