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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSD8432 dose 1 | Experimental | SSD8432 dose 1/ritonavir or placebo |
|
| SSD8432 dose 2 | Experimental | SSD8432 dose 2/ritonavir or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSD8432 dose 1/Ritonavir | Drug | Cohort 1:SSD8432/ritonavir or placebo, on day 1 ~day5,BID; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Frequency of TEAE | Baseline through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Changes of viral load compared to the baseline | Baseline through Day 28 |
| Time to Sustained Alleviation | Time to Sustained Alleviation of Targeted COVID-19 Signs/Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yumei Yang | Jiangsu Xiansheng Pharmaceutical Co., LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Third People's Hospital | Shenzhen | Guangdong | 518100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40965470 | Derived | Yao B-F, Yang Y, Xu S-S, Tang B-H, Chen J, Guo Z-J, Hu H-L, Zhang W, Fu S-M, Zhang X-F, Hao G-X, Yang X-M, Song L-L, Ye P-P, Liu L, Zhu S-W, Zheng Y, Zhao W. Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir. Antimicrob Agents Chemother. 2025 Nov 5;69(11):e0061425. doi: 10.1128/aac.00614-25. Epub 2025 Sep 18. | |
| 37484496 |
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| SSD8432 dose 2/Ritonavir | Drug | Cohort 2:SSD8432/ritonavir or placebo, on day 1 ~day5,BID; |
|
|
| Baseline through Day 28 |
| Proportion of Participants Progressing to a Worsening Status (higher score) | WHO clinical progression scale (0 to 10) | Baseline through Day 28 |
| Maximum Plasma Concentration [Cmax] | Plasma Concentration of SSD8432 | Baseline through Day 5 |
| Area Under the Plasma concentration-time Curve [AUC] | Plasma Concentration of SSD8432 | Baseline through Day 5 |
| Derived |
| Wang F, Xiao W, Tang Y, Cao M, Shu D, Asakawa T, Xu Y, Jiang X, Zhang L, Wang W, Tang J, Huang Y, Yang Y, Yang Y, Tang R, Shen J, Lu H. Efficacy and safety of SIM0417 (SSD8432) plus ritonavir for COVID-19 treatment: a randomised, double-blind, placebo-controlled, phase 1b trial. Lancet Reg Health West Pac. 2023 Jul 11;38:100835. doi: 10.1016/j.lanwpc.2023.100835. eCollection 2023 Sep. |