A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZSP0678 and the Effect of Food on ZSP0678 Pharmacokinetics in Chinese Healthy Subjects.

Guangdong Raynovent Biotech Co., Ltd1 site in 1 country104 target enrollmentNovember 19, 2019

Overview

Phase: Phase 1
Intervention: ZSP0678-10mg
Conditions: Nonalcoholic Steatohepatitis
Sponsor: Guangdong Raynovent Biotech Co., Ltd
Enrollment: 104
Locations: 1
Primary Endpoint: Tmax
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single-and multiple-oral doses of ZSP0678 on fasted condition, and characterize PK of ZSP0678 on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence manner. The study will be conducted in 3 parts (Ascending single dose, multiple dose and food effect). Participants will receive either ZSP0678 or placebo .

Registry

clinicaltrials.gov

Start Date

November 19, 2019

End Date

December 9, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Guangdong Raynovent Biotech Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects are required to meet the following criteria in order to be included in the trial:
•Signature signed informed consent before the trial, and fully understood the content, process and possible adverse reactions.
•Subjects must be willing and able to complete the research according to the experimental protocol.
•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.
•Male and female subjects aged 18-50 (including 18 and 50)
•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);
•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 Criteria

•Eligible subjects must not meet any of the following exclusion criteria:
•Allergic constitution (allergic to many drugs, especially to ingredients similar to the test drug and food)
•The average daily smoking are more than 5 cigarettes within 3 months prior to screening.
•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 )
•Subjects who donated blood or bleeding profusely(\> 400 mL)in the 3 months preceding study screening.
•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.
•History or presence of any disease or condition known to increase the risk of bleeding, eg.acute gastritis, duodenal ulcer, etc.
•Participated in another clinical research study and received any investigational products within 3 months prior to dosing.
•Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal 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.

Arms & Interventions

ZSP0678-10mg (single dose)-Cohort 1

ZSP0678/Placebo 10mg

Intervention: ZSP0678-10mg