Status:
COMPLETED
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
Lead Sponsor:
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Conditions:
Nonalcoholic Steatohepatitis (NASH)
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty sto...
Detailed Description
The study is a randomized, double-blind phase 1 trial including 3 parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics part.The primary aims of th...
Eligibility Criteria
Inclusion
- Subjects are required to meet the following criteria in order to be included in the trial:
- Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subjects(including partners)have no gestation plans and must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
- Males and female subjects between 18-50 years (Both inclusive).
- Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18≤BMI≤28 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
- Physical condition:No significant abnormalities in medical history, including cardiovascular system, liver, kidneys, gastrointestinal system, neural system, respiratory system (eg.asthma,asthma induced by exercise,chronic obstructive pulmonary disease), mental, metabolism, etc.
- Subjects in general good health or No significant abnormalities in the opinion of the investigator as determined by vital signs and a physical examination.
Exclusion
- Eligible subjects must not meet any of the following exclusion criteria:
- The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
- Known hypersensitivity and/or allergy to some drugs and food.
- Known history of drug or alcohol abuse.(defined as consumption of 14 units of alcohol per week:1 unit=285ml of beer; or the equivalent of 25ml of spirit, or 100ml of wine )
- Subjects who donated blood or bleeding profusely(\> 400 mL)in the 3 months preceding study screening.
- Dysphagia or any medical history in gastrointestinal that interferes with the absorption of drugs.
- History or presence of any disease or condition known to increase the risk of bleeding, eg.acute gastritis, duodenal ulcer, etc.
- Frequently suffers from postural hypotension.
- History of frequent nausea or vomit causes by any etiology.
- Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of CYP3A4 prior to screening or during the study.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to screening.
- History of having any special food(including dragon fruit,mango,grapefruit,etc.),strenuous exercises,or other factors may interfere with the absorption, distribution, metabolism, or excretion of drug within 14 days prior to screening.
- Subjects with recent significant change in diet or exercise .
- Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
- Inability to consume the food provided in the study ( a high fat, high calorie meal includes two eggs for 100g, bacon 20g, a butter toast for 50g, french fries for 115g, whole milk for 240ml).This requirement only applies to subjects under fed condition.
- Presence of clinically significant abnormalities in ECG or QTc\>470ms in males,or QTc\>480ms in females.
- Pregnancy or breastfeeding at screening and during the study.All female subjects of childbearing potential must have a negative urine pregnancy test at screening and during the trial.
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
- Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ),treponema pallidum antibodies at screening.
- Any acute illness or concomitant medication from screening to first dosing.
- Have chocolate, any food or beverage that contains caffeine or xanthine within 24 hours prior to dosing.
- Take any product contains alcohol within 24 hours prior to dosing.
- Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening.
Key Trial Info
Start Date :
January 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03392779
Start Date
January 5 2018
End Date
March 22 2019
Last Update
August 13 2019
Active Locations (1)
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1
The First Hospital of Jilin University
Changchun, Jilin, China, 130021