NCT05339646

A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

A Phase I, Single and Multiple Dose, to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 and SSD8432 Co-administrated in Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects

Detailed description

108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study. This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-04-07
• Primary completion: 2022-10-01
• Completion: 2022-12-01
• First posted: 2022-04-21
• Last updated: 2022-04-21

Locations

1 site across 1 country: China