PsoriasisPhase 1NCT06380153
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment
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 aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal 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
- 26 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2024to 16 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 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 18-70 years old (both ends, whichever is based on written informed consent);
- 3. The body weight of male subjects was not less than 50 kg and that of female subjects was not less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
- 4.The creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) of the subjects met the CKD staging criteria of the corresponding groups, namely mild renal impairment: 60≤CLcr<90 mL/min; Moderate renal impairment: 30≤CLcr<60mL/min. At the same time, according to the investigator's judgment, the creatinine clearance rate of the subjects was not expected to change significantly by the end of the study.
- 5. Stable renal function: the interval between two creatinine tests was at least 3 days (30 days before the first test result was acceptable), and the fluctuation value of serum creatinine results between the two tests (calculated by the formula: (the second result-the first result)/the first result) was less than 30%;
- 6.no new concomitant medications in the 2 weeks before screening, no adjustment in the treatment regimen (including the type, dose, or frequency of medications) for underlying diseases in the 4 weeks before screening, and no change in the treatment regimen (except for drugs used temporarily on demand) during the study (except as specified in the protocol), or no medication was used;
- 7.In addition to renal impairment 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, etc.), and no other clinically significant abnormalities.
Who cannot join
- 1.(Inquired) The subject has any of the following conditions: acute kidney failure, a history of kidney transplantation, or a need for kidney transplantation or any type of dialysis during the planned trial period; Patients with urinary incontinence or anuria; Patients with obstructive urinary tract diseases (such as urinary tract obstruction caused by urinary calculi, urinary tract obstruction caused by abdominal space occupying lesions, etc.), and the investigator thought that they were not suitable;
- 2. (Inquiry) In addition to the disease causing renal impairment, patients with serious acute or chronic diseases of other vital organs within 1 year prior to screening, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system and other systems, who were judged by the investigator to be not suitable for the trial;
- 3. (Inquiry) Any of the following occurred in the 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. (inquiring) patients with a history of depression or suicidal tendencies;
- 5. (inquiry) patients who had severe gastrointestinal diseases or had digestive system surgery within 3 months before screening, which affected drug absorption according to the investigator;
- 6.(inquiry) blood loss or donation of more than 400mL within one month before screening, or red blood cell transfusion;
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- 7. Screening laboratory test results met any of the following: (a) alanine aminotransferase (ALT) >2 times the normal value; (b) total bilirubin >1.5 times the normal value; (c) neutrophil count <1.3×109/L; (d) hemoglobin <80g/L; (e) platelet count <80×109/L;
- 8.(inquiry) 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.);
- 9. (queried) drug users in the past 3 years or drug abuse in the past 5 years;
- 10. screening positive for drug abuse (excluding those screened positive for drug abuse due to concomitant medications);
- 11. with positive breath alcohol test (alcohol concentration >0mg/L);
- 12. (inquired) drank 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 could not abstain from alcohol during the study;
- 13.(inquired) smoked more than 5 cigarettes per day in the 3 months before screening, or could not stop using any tobacco products during the study;
- 14. (questionnaire) consuming excessive amounts of tea, coffee and/or caffeine-rich beverages (> 8 cups, 1 cup =250 mL) per day in the previous 3 months;
- 15. Hepatitis B, hepatitis C, HIV and syphilis tests have one or more clinical significance;
- 16. (inquiry) who had participated in and used other drug/device clinical trials within 3 months before screening;
- 17. (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);
- 18. (inquiry) who had used prescription drugs, over-the-counter drugs, health supplements, herbal products or vaccines other than those used to treat renal impairment and other concomitant diseases within 2 weeks before screening;
- 19. (inquiry) consumed any caffeine/xanthine/food or drink (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine/xanthine/which may affect the absorption, distribution, metabolism, and excretion of the drug in the investigator's decision from screening to -1 day of admission, or could not stop consuming the above food or drink during the study;
- 20. (inquiry) pregnant or lactating women, or subjects (including male subjects) who have plans to have children or to donate sperm or eggs from two weeks before the study to six months after the last dose of the study, and who are unwilling or unable to use effective contraception;
- 21.(inquiry) unable to eat or have swallowing difficulties, have special dietary requirements and/or cannot follow a uniform diet;
- 22. (inquiry) with a history of epileptic seizures;
- 23. (inquiry) can not tolerate venipuncture and/or have a history of dizziness;
- 24.subjects with other factors considered by the investigator to be ineligible for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital of Tongji Medical College; Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Mild and Moderate Renal Impairment and Normal Renal Function After a Single Oral Administration
The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment.
Read the detailed description
To evaluate the pharmacokinetics and safety of Hemay 005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal 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 renal impairment group | Experimental | 15mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 Receives: Drug: Hemay005 |
| Moderate renal impairment 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
Relevant pharmacokinetic parameters ，Renal clearance rate（CLr）
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 posted23 Apr 2024
- Study start7 May 2024
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiyong Li, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380153
- Sponsor's protocol ID
- HM005PS1S07
- Status last verified
- Apr 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 and Moderate Renal Impairment and Normal Renal Function After a Single Oral Administration
- ClinicalTrials.gov ID
- NCT06380153
- Acronym / sponsor ID
- HM005PS1S07
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 23 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 aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment.
Detailed description
To evaluate the pharmacokinetics and safety of Hemay 005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal 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 renal impairment group | Experimental | Drug: Hemay00515mg/tablet，Four tablets (60mg) each time. Participants will receive a single dose of Hemay005 tablet in Day1 |
| Moderate renal impairment 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 (7 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 18-70 years old (both ends, whichever is based on written informed consent);
- 3. The body weight of male subjects was not less than 50 kg and that of female subjects was not less than 45 kg. Body mass index (BMI) : 19-32 kg/m2 (including cut-off value);
- 4.The creatinine clearance rate (CLcr, calculated by Cockcroft-Gault formula) of the subjects met the CKD staging criteria of the corresponding groups, namely mild renal impairment: 60≤CLcr<90 mL/min; Moderate renal impairment: 30≤CLcr<60mL/min. At the same time, according to the investigator's judgment, the creatinine clearance rate of the subjects was not expected to change significantly by the end of the study.
- 5. Stable renal function: the interval between two creatinine tests was at least 3 days (30 days before the first test result was acceptable), and the fluctuation value of serum creatinine results between the two tests (calculated by the formula: (the second result-the first result)/the first result) was less than 30%;
Key exclusion criteria (24 listed)
- 1.(Inquired) The subject has any of the following conditions: acute kidney failure, a history of kidney transplantation, or a need for kidney transplantation or any type of dialysis during the planned trial period; Patients with urinary incontinence or anuria; Patients with obstructive urinary tract diseases (such as urinary tract obstruction caused by urinary calculi, urinary tract obstruction caused by abdominal space occupying lesions, etc.), and the investigator thought that they were not suitable;
- 2. (Inquiry) In addition to the disease causing renal impairment, patients with serious acute or chronic diseases of other vital organs within 1 year prior to screening, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system and other systems, who were judged by the investigator to be not suitable for the trial;
- 3. (Inquiry) Any of the following occurred in the 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. (inquiring) patients with a history of depression or suicidal tendencies;
- 5. (inquiry) patients who had severe gastrointestinal diseases or had digestive system surgery within 3 months before screening, which affected drug absorption according to the investigator;
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 renal impairment group, Moderate renal impairment 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
Relevant pharmacokinetic parameters ，Renal clearance rate（CLr）
Time frame: Day1-Day6
All subjects who receive the drug will be analyzed for pharmacokinetic
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 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. This study is not recruiting at the moment.
Weiyong Li principal investigator
Study Principal Investigator
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 7 inclusion and 24 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 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?
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?
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） (time frame: Day1-Day6). The study lists 7 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.