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A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

NCT05339646 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2022-04-21

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yumei Yang · Jiangsu Simcere Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05339646 on ClinicalTrials.gov