Healthy PersonPhase 1NCT06432738
ZL-82 Double-blind Clinical Trial
A Phase 1 study testing ZL-82 in people with Healthy Person, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 (Janus kinase 3, JAK3) developed by Chengdu Zenitar Biomedical Technology Co., Ltd. According to Document No. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Person
- What is being tested?
- ZL-82
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2024to 15 Aug 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who can understand the informed consent form, voluntarily participate in the trial and sign the informed consent form.
- Male or female; aged between 18 and 50 years old (including 18 and 50 years old).
- Male subjects weigh >=50kg, female subjects weigh >=45kg, body mass index (BMI) between 19.0~26.0kg/m^2, BMI = weight (kg)/height^ 2 (m^2), including boundary values.
- The subject can communicate well with the researcher and complete the trial in compliance with the requirements of the protocol.
Who cannot join
- -
- Subjects who meet any of the following criteria will be excluded from the trial:
- Current medical history, past medical history, and recent medication history:
- Those who have a history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, respiratory system, etc.), mental illness, and drug dependence;
- Have a history of structural heart disease, heart failure, myocardial infarction, angina pectoris, torsade de pointes, ventricular tachycardia, QT prolongation syndrome or symptoms of QT prolongation syndrome (such as syncope) , convulsions) and family history (proven hereditary or close relatives died suddenly due to cardiac causes when young);
- Physical examination, vital signs, laboratory examination items and test-related examinations and tests during the screening period or baseline period (for example: chest X-ray examination, abdominal color ultrasound, blood pregnancy test, ANA examination, gamma-interferon release Test, 12-lead electrocardiogram, etc.) with abnormal results and clinical significance;
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- Patients with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia;
- Nervous/psychiatric, respiratory system, cardiovascular system, digestive tract system, blood and lymphatic system, endocrine system, musculoskeletal system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the test results during screening By;
- Those with allergies, or those with a history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) that are clinically significant as determined by the researcher; or those who are known to be allergic to JAK inhibitors or to the test Those who are allergic to the excipients contained in the medicine;
- Those who have suffered from clinically significant diseases or undergone major surgeries within 3 months before screening;
- Those who suffered from acute diseases within 2 weeks before screening; those who had clinically significant infections within 3 months before screening (such as upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.); those who had any evidence of infection within 7 days before screening (such as Fever, cough, sputum, headache, etc.); those with a history of herpes simplex infection or recurrent (>1 time) herpes zoster or disseminated herpes zoster;
- Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption;
- Those who have donated blood within 3 months before screening, or those who plan to donate blood during this trial, or those who have had blood transfusion or blood loss ≥ 200mL within 4 weeks before the trial;
- Those who have participated in 4 or more clinical trials as subjects in the past year; or those who have participated in any clinical trials as subjects within 3 months before participating in this trial;
- Those who have a history of drug abuse within 5 years before screening or have used drugs within 3 months before screening;
- Concomitant use of strong inducers of liver metabolic enzymes (such as: omeprazole, barbiturates, carbamazepine, aminoglutethimide, griseofulvin, promethazine) within 4 weeks (28 days) before screening esters, phenytoin, gramide, rifampicin, sulfinpyrazone, roxithromycin, etc.); those who have taken any drug known to cause QT/QTc interval prolongation within 4 weeks (28 days) before screening or have Medications that pose a risk of torsade de pointes (TdP);
- Those who have been vaccinated within 8 weeks before screening, or plan to be vaccinated during the study or within 8 weeks after the last dose of study drug;
- Those who have a history of fainting from blood and needles and cannot tolerate blood collection with intravenous indwelling needles;
- Health status:
- Those whose 12-lead electrocardiogram during the screening period or baseline period has the following results: QTcF interval corrected according to Fridericia's formula >450ms; or those whose electrocardiogram is abnormal and the researcher believes that the abnormality is clinically significant (including but not limited to complete left bundle branch or right bundle branch block; second or third degree atrioventricular block (AVB); sustained atrial or ventricular arrhythmias; two consecutive ventricular premature contractions; ST-segment elevation pattern and myocardial ischemia Consistent; evidence of previous myocardial infarction (MI), left ventricular hypertrophy (LVH), or more than mild nonspecific ST-T wave changes; any features that make QT assessment unreliable, including flattened T waves);
- Those with systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg during the screening period or baseline period;
- Laboratory test results during the screening period or baseline period that the researcher considers to be abnormal and clinically significant, including but not limited to:
- Abnormal renal function during the screening period or baseline period: serum creatinine > upper limit of normal (ULN) or glomerular filtration rate (GFR, calculated by CKD-EPI formula) <90mL/min/1.73m2;
- Direct bilirubin and total bilirubin>1.5xULN;
- Those who are positive for hepatitis B virus surface antigen and/or positive for hepatitis B virus e antigen, positive for hepatitis C virus antibodies, positive for human immunodeficiency virus antibodies, or have abnormal Treponema pallidum antibodies during the screening period;
- Those who have a positive alcohol breath test during the screening period or baseline period, or a positive urine drug abuse screen;
- Lifestyle restrictions:
- Have special requirements for diet and cannot comply with the diet and corresponding regulations provided by clinical research institutions;
- Those who cannot control special diets (including dragon fruit, mango, grapefruit and/or xanthine diets, caffeinated foods or beverages, etc.) from 48 hours before the first dose to the end of the study;
- Those who have taken special diets or exercised strenuously within 48 hours before the first dose, or have other factors that affect drug absorption, distribution, metabolism, excretion, etc.;
- Regular drinkers within 6 months before administration or during the trial, that is, drinking more than 21 units (men) or 14 units (women) of alcohol per week (1 unit = 360mL beer or 45mL liquor with an alcohol content of 40%) or 150mL wine);
- Those who smoked more than 5 cigarettes per day in the 3 months before administration, or who will use any tobacco products during the trial; contraception:
- Pregnant or lactating women or those with positive blood pregnancy test results;
- Those who have used long-acting estrogen or progesterone injections or implants within 6 months before screening;
- Women of childbearing age who had unprotected sex with their partners within 14 days before screening;
- Male or female subjects of childbearing potential do not agree to use effective contraceptive methods from the time of signing the informed consent form to 6 months after the last dose.
- Other standards:
- Subjects who the researcher believes have poor compliance or have any factors that are not suitable for participating in this trial;
- Relevant personnel of the research center and their family members;
- Vulnerable subjects such as students and subordinates of researchers and employees of sponsors;
- Subjects may not be able to complete this trial due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Medical Shandong Hospital of Traditional Chinese Medicine
Zibo, Shandong, 255000
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Design to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and QTc Effect Research
ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 (Janus kinase 3, JAK3) developed by Chengdu Zenitar Biomedical Technology Co., Ltd. According to Document No. 44 of 2020 "Chemical Drug Registration Classification and Application Document Requirements", it belongs to Category 1 chemical drugs and is an innovative drug that has not been marketed at home or abroad.
ZL-82 tablets have completed non-clinical pharmacology, non-clinical PK, and toxicology experiments, and have obtained the first-in-human randomized double-blind, placebo-controlled, dose-increasing dose-increasing approval for single oral administration of ZL-82 tablets. Partial results of the phase I clinical study on safety tolerability, pharmacokinetics and preliminary pharmacodynamics. It is necessary to further explore the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of multiple administrations based on the results obtained from the first human trial.
Read more
Non-clinical in vitro hERG tests and in vivo animal safety pharmacology tests of ZL-82 tablets showed no relevant cardiac safety concerns. According to the ICH E14 guideline "Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs" Evaluation》2, it is recommended to conduct cardiac safety evaluation of experimental drugs with systemic bioavailability to evaluate the impact of experimental drugs on cardiac safety. This evaluation should include evaluation of the effect of the new drug on the QT/QTc interval and collection of adverse cardiovascular events. Establishing a relationship between ZL-82 drug concentration and QT/QTc interval changes will provide additional information for the analysis of cardiac repolarization trial planning and interpretation to facilitate analysis of the effects of drugs on QT/QTc interval changes. Concentration-response analysis, used to characterize the effect of the test drug on the QT/QTc interval, can be used as an alternative to time point analysis.
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of ZL-82 tablets in single/multiple oral doses in healthy subjects, and will also evaluate the effect of ZL-82 tablets on QTc.
- Conditions
- Healthy Person
- Being tested
- ZL-82, ZL-82 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-82Drug
Also called 600mg ZL-82, 50mg ZL-82, 100mg ZL-82, 200mg ZL-82
This group of subjects take ZL-82
ZL-82 placeboDrug
Also called 600mg ZL-82 placebo, 50mg ZL-82 placebo, 100mg ZL-82 placebo, 200mg ZL-82 placebo
This group of subjects take ZL-82 placebo
| Study group | Role | What they receive |
|---|---|---|
| 600mg ZL-82 | Experimental | The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up. Receives: Drug: ZL-82 |
| 600mg ZL-82 placebo | Placebo comparator | The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up. Receives: Drug: ZL-82 placebo |
| 50mg ZL-82 | Experimental | Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. Receives: Drug: ZL-82 |
| 50mg ZL-82 placebo | Placebo comparator | Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. Receives: Drug: ZL-82 placebo |
| 100mg ZL-82 | Experimental | Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. Receives: Drug: ZL-82 |
| 100mg ZL-82 placebo | Placebo comparator | Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. Receives: Drug: ZL-82 placebo |
| 200mg ZL-82 | Experimental | Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. Receives: Drug: ZL-82 |
| 200mg ZL-82 placebo | Placebo comparator | Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. Receives: Drug: ZL-82 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ZL-82 Pharmacokinetics (PK)：Cmax
security indicators
Measured: 72hours
ZL-82 Pharmacokinetics (PK)：Tmax
Estimation of time to reach Cmax
Measured: 72hours
ZL-82 Pharmacokinetics (PK)：AUC0-72h
Estimation of AUC from time zero to the last measured time point
Measured: 72hours
ZL-82Pharmacokinetics (PK)：AUC0-∞
Estimation of AUC from time zero extrapolated to infinity
Measured: 72hours
ZL-82 Pharmacokinetics (PK)：MRT
Estimation of mean residence time
Measured: 72hours
ZL-82 Pharmacokinetics (PK)：Vd
Estimation of apparent volume of distribution
Measured: 72hours
ZL-82 Pharmacokinetics (PK)：t1/2
Estimation of terminal elimination half-life
Measured: 72hours
ZL-82 Pharmacokinetics (PK)：CLz/F
Estimation of clearance when dosed orally
Measured: 72hours
Secondary outcomes (3)
Evaluation of the pharmacodynamic (PD) characteristics of single/multiple oral doses of ZL-82 tablets in healthy humans
security indicators
Measured: Day 16
To evaluate the effect of ZL-82 tablets on QT/QTc interval in healthy subjects after single-dose administration.
security indicators
Measured: Day 16
To evaluate the effect of ZL-82 tablets on ECG parameters (ΔQTcF/ΔΔQTcF and HR, PR, QRS intervals) in healthy subjects, as well as the effect on T wave morphology and U wave.
security indicators
Measured: Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start19 Mar 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PersonStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432738
- Sponsor's protocol ID
- ZL82-H-Ib
- Status last verified
- Sep 2025
- First submitted
- 24 Mar 2024
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Design to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and QTc Effect Research
- ClinicalTrials.gov ID
- NCT06432738
- Acronym / sponsor ID
- ZL82-H-Ib
- Conditions
- Healthy Person
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 29 May 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.
ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 (Janus kinase 3, JAK3) developed by Chengdu Zenitar Biomedical Technology Co., Ltd. According to Document No. 44 of 2020 "Chemical Drug Registration Classification and Application Document Requirements", it belongs to Category 1 chemical drugs and is an innovative drug that has not been marketed at home or abroad.
ZL-82 tablets have completed non-clinical pharmacology, non-clinical PK, and toxicology experiments, and have obtained the first-in-human randomized double-blind, placebo-controlled, dose-increasing dose-increasing approval for single oral administration of ZL-82 tablets. Partial results of the phase I clinical study on safety tolerability, pharmacokinetics and preliminary pharmacodynamics. It is necessary to further explore the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of multiple administrations based on the results obtained from the first human trial.
Non-clinical in vitro hERG tests and in vivo animal safety pharmacology tests of ZL-82 tablets showed no relevant cardiac safety concerns. According to the ICH E14 guideline "Clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects of Non-Antiarrhythmic Drugs" Evaluation》2, it is recommended to conduct cardiac safety evaluation of experimental drugs with systemic bioavailability to evaluate the impact of experimental drugs on cardiac safety. This evaluation should include evaluation of the effect of the new drug on the QT/QTc interval and collection of adverse cardiovascular events. Establishing a relationship between ZL-82 drug concentration and QT/QTc interval changes will provide additional information for the analysis of cardiac repolarization trial planning and interpretation to facilitate analysis of the effects of drugs on QT/QTc interval changes. Concentration-response analysis, used to characterize the effect of the test drug on the QT/QTc interval, can be used as an alternative to time point analysis.
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of ZL-82 tablets in single/multiple oral doses in healthy subjects, and will also evaluate the effect of ZL-82 tablets on QTc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 600mg ZL-82 | Experimental | Drug: ZL-82The subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up. |
| 600mg ZL-82 placebo | Placebo comparator | Drug: ZL-82 placeboThe subjects in the single-dose group were fasted and water-free for at least 10 hours the night before the administration. On the first day of the study (D1), the subjects were given ZL-82 tablets or placebo according to the requirements of the random table, and were followed as per the study. Schedule safety inspections and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; complete a series of safety inspections, PK, and PD sample collection on the 3rd day and leave the clinical trial facility on the 7th day Safety follow-up. |
| 50mg ZL-82 | Experimental | Drug: ZL-82Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. |
| 50mg ZL-82 placebo | Placebo comparator | Drug: ZL-82 placeboSubjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. |
| 100mg ZL-82 | Experimental | Drug: ZL-82Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. |
| 100mg ZL-82 placebo | Placebo comparator | Drug: ZL-82 placeboSubjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. |
| 200mg ZL-82 | Experimental | Drug: ZL-82Subjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. |
| 200mg ZL-82 placebo | Placebo comparator | Drug: ZL-82 placeboSubjects in the multiple-dose group were fasted and water-free for at least 10 hours the night before dosing, and were given ZL once a day according to the random table requirements from day 1 (D1) to day 10 (D10) of the study. -82 tablets or placebo, and undergo safety inspections according to the study schedule and complete PK, PD, and Holter collection according to the PK, PD, and Holter collection schedule; after completing a series of safety inspections, PK, and PD sample collection on day 12 Safety follow-up was conducted on day 16 after leaving the clinical trial facility. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Those who can understand the informed consent form, voluntarily participate in the trial and sign the informed consent form.
- Male or female; aged between 18 and 50 years old (including 18 and 50 years old).
- Male subjects weigh >=50kg, female subjects weigh >=45kg, body mass index (BMI) between 19.0~26.0kg/m^2, BMI = weight (kg)/height^ 2 (m^2), including boundary values.
- The subject can communicate well with the researcher and complete the trial in compliance with the requirements of the protocol.
Key exclusion criteria (41 listed)
- -
- Those who have a history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, respiratory system, etc.), mental illness, and drug dependence;
- Have a history of structural heart disease, heart failure, myocardial infarction, angina pectoris, torsade de pointes, ventricular tachycardia, QT prolongation syndrome or symptoms of QT prolongation syndrome (such as syncope) , convulsions) and family history (proven hereditary or close relatives died suddenly due to cardiac causes when young);
- Physical examination, vital signs, laboratory examination items and test-related examinations and tests during the screening period or baseline period (for example: chest X-ray examination, abdominal color ultrasound, blood pregnancy test, ANA examination, gamma-interferon release Test, 12-lead electrocardiogram, etc.) with abnormal results and clinical significance;
- Patients with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia;
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 |
|---|---|---|
| ZL-82Also: 600mg ZL-82, 50mg ZL-82, 100mg ZL-82, 200mg ZL-82This group of subjects take ZL-82 | Drug | 100mg ZL-82, 200mg ZL-82, 50mg ZL-82, 600mg ZL-82 |
| ZL-82 placeboAlso: 600mg ZL-82 placebo, 50mg ZL-82 placebo, 100mg ZL-82 placebo, 200mg ZL-82 placeboThis group of subjects take ZL-82 placebo | Drug | 100mg ZL-82 placebo, 200mg ZL-82 placebo, 50mg ZL-82 placebo, 600mg ZL-82 placebo |
Primary outcome
ZL-82 Pharmacokinetics (PK)：Cmax
Time frame: 72hours
security indicators
ZL-82 Pharmacokinetics (PK)：Tmax
Time frame: 72hours
Estimation of time to reach Cmax
ZL-82 Pharmacokinetics (PK)：AUC0-72h
Time frame: 72hours
Estimation of AUC from time zero to the last measured time point
ZL-82Pharmacokinetics (PK)：AUC0-∞
Time frame: 72hours
Estimation of AUC from time zero extrapolated to infinity
ZL-82 Pharmacokinetics (PK)：MRT
Time frame: 72hours
Estimation of mean residence time
ZL-82 Pharmacokinetics (PK)：Vd
Time frame: 72hours
Estimation of apparent volume of distribution
ZL-82 Pharmacokinetics (PK)：t1/2
Time frame: 72hours
Estimation of terminal elimination half-life
ZL-82 Pharmacokinetics (PK)：CLz/F
Time frame: 72hours
Estimation of clearance when dosed orally
3 secondary outcomes
Evaluation of the pharmacodynamic (PD) characteristics of single/multiple oral doses of ZL-82 tablets in healthy humans
Time frame: Day 16
To evaluate the effect of ZL-82 tablets on QT/QTc interval in healthy subjects after single-dose administration.
Time frame: Day 16
To evaluate the effect of ZL-82 tablets on ECG parameters (ΔQTcF/ΔΔQTcF and HR, PR, QRS intervals) in healthy subjects, as well as the effect on T wave morphology and U wave.
Time frame: Day 16
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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Virus-HIV
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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 study testing ZL-82 in people with Healthy Person, run by Chengdu Zenitar Biomedical Technology 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 4 inclusion and 41 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 1 Oct 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 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?
ZL-82 Pharmacokinetics (PK)：Cmax (time frame: 72hours). The study lists 8 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 1 Oct 2025.