A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

PHASE1UnknownINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

April 7, 2022

Primary Completion Date

October 31, 2022

Study Completion Date

December 31, 2022

Conditions
Healthy Participants
Interventions
DRUG

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."

DRUG

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.

DRUG

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

DRUG

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"

DRUG

SSD8432 dose 14 and Ritonavir

Cohort 11: to be decided

Trial Locations (1)

250014

RECRUITING

The First Affiliated Hospital of Shandong First Medical University, Jinan

All Listed Sponsors
lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY