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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Cohort 1:SSD8432/ritonavir or placebo, on day 1 \~day5,BID;
Cohort 2:SSD8432/ritonavir or placebo, on day 1 \~day5,BID;
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China
Adverse events
Frequency of TEAE
Time frame: Baseline through Day 28
Viral load
Changes of viral load compared to the baseline
Time frame: Baseline through Day 28
Time to Sustained Alleviation
Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms
Time frame: Baseline through Day 28
Proportion of Participants Progressing to a Worsening Status (higher score)
WHO clinical progression scale (0 to 10)
Time frame: Baseline through Day 28
Maximum Plasma Concentration [Cmax]
Plasma Concentration of SSD8432
Time frame: Baseline through Day 5
Area Under the Plasma concentration-time Curve [AUC]
Plasma Concentration of SSD8432
Time frame: Baseline through Day 5
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