To Evaluate SSD8432/ Ritonavir in Adults With COVID-19

Phase 1/2 Completed 32 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2022-05-12
Primary completion: 2022-08-29
Completion: 2022-08-29

Publications

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.
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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	simnotrelvir	Small molecule	300 mg	Oral
Subject	simnotrelvir	Small molecule	750 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	—

Indications

No indication recorded.