A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

Study Overview
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Brief Summary
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This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.

Official Title
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A Randomized, Open-Label, Phase I Clinical Study on SHR6390 of Different Specifications After Process Modification in Healthy Chinese Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SHR6390(100mg)
* Drug: SHR6390(125mg)
* Drug: SHR6390(150mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study. Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease. No pregnancy plan during the trial or within 6 months after completion of the trial. Voluntarily signed the informed consent form and strictly adherence to the study protocol. Exclusion Criteria: vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance. Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive; Any history of allergy, alcohol and drug abuse; blood donation, massive blood loss (≥400mL). Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening; use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening; use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening; A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR6390（100mg）<br> | Drug: SHR6390(100mg)<br>* SHR6390 at a single oral dose of 100 mg.<br>|
| Experimental: SHR6390（125mg）<br> | Drug: SHR6390(125mg)<br>* SHR6390 at a single oral dose of 125 mg.<br>|
| Experimental: SHR6390（150mg）<br> | Drug: SHR6390(150mg)<br>* SHR6390 at a single oral dose of 150 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | 12 days | 
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 12 days | 
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Collection of adverse events | 22 days | 
| Incidence of abnormal blood pressure | Monitor both systolic and diastolic blood pressure | 22 days | 
| Incidence of abnormal temperature | Monitor the temperature | 22 days | 
| Incidence of abnormal electrocardiogram waveform | Electrocardiogram inspection | 22 days |