Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics
NCT ID: NCT04137055
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
104 participants
INTERVENTIONAL
2019-11-19
2020-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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ZSP0678-10mg (single dose)-Cohort 1
ZSP0678/Placebo 10mg
ZSP0678-10mg
ZSP0678 tablet administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678-30mg (single dose)-Cohort 2
ZSP0678/Placebo 30 mg Enrollment into Cohort 2 will begin upon assurance of safety for Cohort 1.
ZSP0678-30mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678-60mg (single dose)-Cohort 3
ZSP0678/Placebo 60mg Enrollment into Cohort 3 will begin upon assurance of safety for Cohort 2.
ZSP0678-60mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678-120mg (single dose)-Cohort 4
ZSP0678/Placebo 120mg Enrollment into Cohort 4 will begin upon assurance of safety for Cohort 3.
ZSP0678-120mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678-180mg (single dose)-Cohort 5
ZSP0678/Placebo 180mg Enrollment into Cohort 5 will begin upon assurance of safety for Cohort 4.
ZSP0678-180mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678-240mg (single dose)-Cohort 6
ZSP0678/Placebo 240mg Enrollment into Cohort 6 will begin upon assurance of safety for Cohort 5.
ZSP0678-240mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678-320mg (single dose)-Cohort 7
ZSP0678/Placebo 320mg Enrollment into Cohort 7 will begin upon assurance of safety for Cohort 6.
ZSP0678-320mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678 (food effect)-Cohort FE
Period 1: Group A and Group B receive ZSP0678/Placebo under the fasting or fed condition ,respectively on Day1.
Period 2: Group A and Group B receive ZSP0678/Placebo under the fed or fasting condition ,respectively on Day8.
Enrollment into Cohort FE will begin upon assurance of safety for Cohort 4.
ZSP0678
ZSP0678 tablets administered orally under fasted or fed condition
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678 Dose1 (multiple doses)-Cohort 8
ZSP0678/Placebo Dose1 will be administrated according to the results of Cohort 2\&3
ZSP0678-Dose 1
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678 Dose2 (multiple doses)-Cohort 9
ZSP0678/Placebo Dose2 will be administrated according to the results of Cohort 3\&4
ZSP0678-Dose 2
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
ZSP0678 Dose3 (multiple doses)-Cohort 10
ZSP0678/Placebo Dose3 will be administrated according to the results of Cohort 4\&5
ZSP0678-Dose 3
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
Interventions
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ZSP0678-10mg
ZSP0678 tablet administered orally under fasted condition
ZSP0678-30mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678-60mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678-120mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678-180mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678-240mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678-320mg
ZSP0678 tablets administered orally under fasted condition
ZSP0678
ZSP0678 tablets administered orally under fasted or fed condition
ZSP0678-Dose 1
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678-Dose 2
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678-Dose 3
ZSP0678 tablets administered orally once daily for 14 Days
ZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
Eligibility Criteria
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Inclusion Criteria
1. Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions.
2. Subjects must be willing and able to complete the research according to the experimental protocol.
3. Subjects (including partners) are willing to take effective contraceptive measures and have no pregnancy plan during the whole study period until 6 months after drug withdrawal.
4. Male and female subjects aged 18-50 (including 18 and 50)
5. Body weight of male subjects should not be less than 50kg and that of female subjects should not be less than 45kg.Body mass index (BMI) = weight (kg)/height 2 (m2), the range of 19\~26kg/m2 (including the critical value);
6. 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.
7. 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 Criteria
2. The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
3. Known history of drug or alcohol abuse.(defined as consumption of more than 30g of ethanol a day for male and more than 20 g for female )
4. Subjects who donated blood or bleeding profusely(\> 400 mL)in the 3 months preceding study screening.
5. History of dysphagia or any gastrointestinal illness that affects drug absorption, including a history of frequent nausea or vomiting from any cause, irregular gastrointestinal motility, such as habitual diarrhea, constipation, or irritable bowel syndrome.
6. History or presence of any disease or condition known to increase the risk of bleeding, eg.acute gastritis, duodenal ulcer, etc.
7. Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
8. Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening.
9. 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.
10. Subjects who cannot tolerate standard meals (this clause only applies to subjects participating in food impact studies).
11. Presence of clinically significant abnormalities in ECG or QTcB\>450ms in males,or QTcB\>470ms in females.
12. 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.
13. 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).
14. Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ),treponema pallidum antibodies at screening.
15. Any acute illness or concomitant medication from screening to first dosing.
16. Have chocolate, any food or beverage that contains caffeine ,xanthine and alcohol within 24 hours prior to dosing.
17. Positive for urine drug screening or history of substance abuse for a period of 5 consecutive years before screening.
18. As judged by the researcher, it is not suitable to join the clinical researcher.
18 Years
50 Years
ALL
Yes
Sponsors
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Guangdong Raynovent Biotech Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital Affiliated to Capital Medical Universit
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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ZSP0678-19-01
Identifier Type: -
Identifier Source: org_study_id
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