NCT05369676

To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

Randomized, Double-blind, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetic of SSD8432/ Ritonavir Multiple Doses in Treatment of Adults With Asymptomatic Infection, Mild, and Common Type of COVID-19

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety, Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults with COVID-19.

Detailed description

This is a randomized, double-blinded, placebo-controlled, dose-climbing Phase Ib clinical trial, designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of SSD8432/ ritonavir versus placebo in asymptomatic, mild, and common type adult COVID-19 subjects. This clinical trial is planned to enroll 32 asymptomatic infected, mild or common type adult COVID-19 subjects, divided into 2 cohorts according to different doses of SSD8432: Cohort 1: 16 subjects, 12 subjects will receive low-dose SSD8432/ ritonavir, and 4 subjects received placebo; Cohort 2: 16 subjects, 12 subjects will receive high-dose SSD8432/ ritonavir, and 4 subjects received placebo.

Conditions

• COVID-19 Patients

Interventions

Type	Name	Description
DRUG	SSD8432 dose 1/Ritonavir	Cohort 1:SSD8432/ritonavir or placebo, on day 1 \~day5，BID；
DRUG	SSD8432 dose 2/Ritonavir	Cohort 2:SSD8432/ritonavir or placebo, on day 1 \~day5，BID；

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-08-29
• Completion: 2022-08-29
• First posted: 2022-05-11
• Last updated: 2023-05-31

Locations

1 site across 1 country: China