Influenza
Conditions
Brief summary
This is a single center,double-blind,randomized,parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of ZSP1273,and the effect of food on ZSP1273 Pharmacokinetics.
Detailed description
The study will be divided in 3 parts : Study Part I(Single Ascending Dosing, SAD) will be a single ascending dose to be run at a maximum of 6 dose levels. Subjects included in this part of the study will receive only one dose level to limit the exposure to ZSP1273. Four subjects are planned to be included in the first group while 10 subjects are enrolled in every following cohort. Study Part II(Multiple Ascending Dosing, MAD) will start after completion of some Cohorts of Study Part I. Study Part II will be a multiple ascending dose to be run at a maximum of 3 dose levels. Subjects included in this part of the study will receive only one dose level. This part also enrolls 10 subjects in every cohort. Study Part III(Food Effect study, FE) will consists of 2 periods,and subjects will receive a single dose ranged from 100-600mg on fasting and postprandial states respectively. There will be a 7-day wash out period between treatment periods.A total of 12 to 18 subjects will be included. All the 3 parts will be run in healthy subjects.
Interventions
DRUGZSP1273 100 mg
ZSP1273 tablet administered orally once daily under fasted condition
DRUGPlacebo 100 mg
Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state.
DRUGZSP1273 200 mg
ZSP1273 tablets administered orally once daily under fasted condition
DRUGPlacebo 200 mg
Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
DRUGZSP1273 400 mg
ZSP1273 tablets administered orally once daily in the fasting state
DRUGPlacebo 400 mg
Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state
DRUGZSP1273 600 mg
ZSP1273 tablets administered orally once daily under fasted condition
DRUGPlacebo 600 mg
Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
DRUGZSP1273 900 mg
ZSP1273 tablets administered orally once daily in the fasting state
DRUGPlacebo 900 mg
Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
DRUGZSP1273 1200 mg
ZSP1273 tablets administered orally once daily in the fasting state
DRUGPlacebo 1200 mg
Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state
DRUGZSP1273
ZSP1273 tablets administered orally once daily under fasted or fed condition
DRUGPlacebo
Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition
DRUGZSP1273 Low Dose
ZSP1273 tablets administered orally once daily under fasted or fed condition for 5 Days.
DRUGZSP1273 Median Dose
ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
DRUGZSP1273 High Dose
ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
Sponsors
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking for Participant, Investigator and Clinical Research Associate
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 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. 2. Subjects must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study. 3. Subjects (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product. 4. Males and female subjects between 18-50 years (Both inclusive). 5. Body weight is no less than 50 kg in males and no less than 45 kg in females. Body mass index (BMI) 18≤BMI≤28 kg/m2; BMI is determined by the following equation: BMI = weight/height2 (kg/m2). 6. Physical condition and vital signs: Normal or abnormality has no clinical significance.
Exclusion criteria
Eligible subjects must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE) | At day 5, 9, 12 days post first dosing for SAD, MAD, FE part respectively | Number of participants with TEAEs as assessed by CTCAE v5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | UP to 5, 9, 12 days for SAD, MAD, FE part respectively | Maximum concentration (Cmax) |
| t1/2z | UP to 5, 9, 12 days for SAD, MAD, FE part respectively | t1/2z is defined as the time to decline half of the drug concentration in plasma. |
| AUCinf（AUC0-∞） | UP to 5, 9, 12 days for SAD, MAD, FE part respectively | Area under the curve extrapolated until time is infinity (AUCinf) |
| AUClast（AUC0-t） | UP to 5, 9, 12 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, 9, 12 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, 9, 12 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. |
| Tmax | UP to 5, 9, 12 days for SAD, MAD, FE part respectively | The time after dosing when Cmax occurs (Tmax) |
| Food Effect PK Parameter: Fe0-t | UP to 12 days | Fe0-t is defined as the cumulative excretion rate of the drug in urine and feces. |
| Food Effect PK Parameter: Ae | UP to 12 days | Ae is defined as the amount of unchanged drug excreted in urine or faeces after administration. |
| Multiple-dose plasma PK parameter: Rac of ZSP1273 at steady state | Up to 9 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 ZSP1273 at steady state | Up to 9 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 ZSP1273 at steady state | Up to 9 days | Cmin is defined as the minimum observed concentration of drug in plasma at steady state. |
| CLr | UP to 5, 9, 12 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. |
Countries
China
Outcome results
None listed