drugset / Trial / NCT05339646
A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
Timeline
- Start
- 2022-04-07
- Primary completion
- 2022-10
- Completion
- 2022-12
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.
- Yang XM, Yang Y, Yao BF, Ye PP, Xu Y, Peng SP, Yang YM, Shu P, Li PJ, Li S, Hu HL, Li Q, Song LL, Chen KG, Zhou HY, Zhang YH, Zhao FR, Tang BH, Zhang W, Zhang XF, Fu SM, Hao GX, Zheng Y, Shen JS, Xu YC, Jiang XR, Zhang LK, Tang RH, Zhao W. A first-in-human phase 1 study of simnotrelvir, a 3CL-like protease inhibitor for treatment of COVID-19, in healthy adult subjects. Eur J Pharm Sci. 2023 Dec 1;191:106598. doi: 10.1016/j.ejps.2023.106598. Epub 2023 Sep 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ritonavir | Other / unclassified | 100 mg | — |
| Subject | simnotrelvir | Small molecule | 250 mg | — |
| Subject | simnotrelvir | Small molecule | 750 mg | — |
Indications
No indication recorded.