Nonalcoholic Steatohepatitis
Conditions
Keywords
NASH
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 .
Interventions
DRUGZSP0678-10mg
ZSP0678 tablet administered orally under fasted condition
DRUGZSP0678-30mg
ZSP0678 tablets administered orally under fasted condition
DRUGZSP0678-60mg
ZSP0678 tablets administered orally under fasted condition
DRUGZSP0678-120mg
ZSP0678 tablets administered orally under fasted condition
DRUGZSP0678-180mg
ZSP0678 tablets administered orally under fasted condition
DRUGZSP0678-240mg
ZSP0678 tablets administered orally under fasted condition
DRUGZSP0678-320mg
ZSP0678 tablets administered orally under fasted condition
DRUGZSP0678
ZSP0678 tablets administered orally under fasted or fed condition
DRUGZSP0678-Dose 1
ZSP0678 tablets administered orally once daily for 14 Days
DRUGZSP0678-Dose 2
ZSP0678 tablets administered orally once daily for 14 Days
DRUGZSP0678-Dose 3
ZSP0678 tablets administered orally once daily for 14 Days
DRUGZSP0678 Placebo
Participants will receive placebo matching to ZSP0678 orally.
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects are required to meet the following criteria in order to be included in the trial: 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
* Eligible subjects must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of adverse events (AEs) and Serious Adverse Events(SAE) following oral doses of ZSP0678 and placebo. | SAD Group: Up to 5 days, MAD: Up to 18 days, FE group: Up to11 days after first dose ] | — |
| Tmax | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | The time after dosing when Cmax occurs |
| Cmax | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | Maximum concentration |
| t1/2 | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | t1/2 is defined as the time to decline half of the drug concentration in plasma. |
| AUCinf（AUC0-∞） | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | Area under the curve extrapolated until time is infinity (AUCinf) |
| AUClast（AUC0-t） | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration. |
| CL/F | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | CL/F is defined as the ratio of total clearance(Cl) to bioavailability(F). |
| λz | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | λz is defined as the ratio between the elimination of compound per unit time and the total amount of compound. |
| CLr | UP to 5, 18, 11 days for SAD, MAD, FE part respectively | CLr is defined as how many milliliters of plasma in which some substance can be completely eliminated in the unit time (per minute) of two kidneys. |
| Multiple-dose plasma PK parameter: Rac of ZSP0678 at steady state | UP to 18 days. | Rac (Accumulation Index) is defined as the ratio between AUC0-XX in Day XX and AUC0-XX in Day1 |
| Multiple-dose plasma PK parameter: DF of ZSP0678 at steady state | UP to 18 days. | DF is defined as the percentage of fluctuation in steady state is 100 \* (Cmax, ss - Cmin, ss)/Cavg, ss. |
| Multiple-dose plasma PK parameter: Cmin of ZSP0678 at steady state | UP to 18 days. | Cmin is defined as the minimum observed concentration of drug in plasma at steady state. |
Countries
China
Outcome results
None listed