A Phase I Study of KC1036 on Pharmacokinetics to Assess the Effect of High Fat Diet in Chinese Adult Healthy Subjects.

KC1036-I-02

The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.

2022-03-10

2022-03-23

2022-03-23

Completed

12

Inclusion Criteria: * 18\~65 years of age, male. * The weight of male subject ≥50kg, 19≤BMI≤26g/m2. * Agree to take adequate contraceptive measures to prevent spouse pregnancy during the clinical trail. * Able to comprehend and willing to sign an informed consent form (ICF). Exclusion Criteria: * Diseases such as liver, kidney, endocrine, cardiovascular, respiratory, nervous, mental, digestive tract, lung, immunity, skin, blood or metabolic disorders that are considered clinically significant by investigator, or have a history of these diseases, or have undergone major surgery, or factors that will endanger the safety of the subject or affect the research results. * Physical examination, vital signs, laboratory examination, 12-ECG and chest film are clinically significant. * Excessive smoking within 3 months before screening. * History of drug and food allergy. * Drinking 14 units of alcohol per week within 6 months prior dosing (1 unit = 360 mL of beer, or 150mL of wine). * Participate in blood donate blood volume≥200mL or blood loss ≥200mL within 3 month prior dosing. * Take any prescription, any over-the-counter medication, traditional Chinese medicines, vitamin products within14 days prior dosing. * Take any clinical trial drugs within 3 months prior dosing. * Dysphagia or history of gastrointestinal diseases affecting drug absorption. * Combined with other viral infections (anti-HCV, anti-HIV positive, anti-TP positive, HBsAg positive) or combined with syphilis infection. * Acute diseases requiring clinical treatment before screening or prior dosing. * Anyone who refuse to stop ingest foods or drinks containing caffeine, alcohol from 48 hours before dosing to the end of the study. * Urine drug positive or drug users within 3 months prior dosing. * The investigator believes that the subjects are not eligible to participate in this trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double cycle, self crossover', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}

2023-10-10