108
Participants
Start Date
April 7, 2022
Primary Completion Date
October 31, 2022
Study Completion Date
December 31, 2022
SSD8432 dose 1~7 and Ritonavir
"Cohort 1 Period 1 single dose of SSD8432 dose 1 or placebo, on day 1. Period 2: single dose of SSD8432 dose 2 or placebo , on day 7. Period 3: single dose of SSD8432 dose 3 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date~Cohort 2:~Period 1 single dose of SSD8432 dose 4 or placebo, on day 1 Period 2: single doses of SSD8432 dose 5 or placebo , on day 7 Period 3: single dose of SSD8432 dose 6 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date~Cohort 3:~single dose of SSD8432 dose 7 or placebo on day1. ritonavir or placebo, before SSD8432 dose 7 and BID on SSD8432 dosing date."
SSD8432 dose 8~9
Cohort 4: SSD8432 dose 8 or placebo, on day 1 \~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 \~day6.
SSD8432 dose 10~12 and ritonavir
Cohort 6: SSD8432 dose 10 or placebo, on day 1 \~day6. Cohort 7: SSD8432 dose 11 or placebo, on day 1 \~day6. Cohort 8: SSD8432 dose 12 or placebo, on day 1 \~day6 Cohort 9: to be decided
SSD8432 dose 13 and Ritonavir
"Cohort 10:~Group A: SSD8432 dose 13, on day1 under fasting condition, on day 6 under fatty food condition, ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date.~Group B: SSD8432 dose 13, on day1 fatty food condition, on day 6 under fasting condition ,Ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date"
SSD8432 dose 14 and Ritonavir
Cohort 11: to be decided
RECRUITING
The First Affiliated Hospital of Shandong First Medical University, Jinan
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY