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This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study.
This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSD8432 dose 1~7 | Experimental | Dose level 1 ~7 of SSD8432 |
|
| SSD8432 dose 8~9 | Experimental | Dose level 8 ~9 of SSD8432 |
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| SSD8432 dose 10~12 | Experimental | Dose level 10 ~12 of SSD8432 |
|
| SSD8432 dose 13 | Experimental | Dose level 13 of SSD8432 |
|
| SSD8432 dose 14 | Experimental | Dose level 14 of SSD8432 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSD8432 dose 1~7 and Ritonavir | Drug | Cohort 1 Period 1 single dose of SSD8432 dose 1 or placebo, on day 1. Period 2: single dose of SSD8432 dose 2 or placebo , on day 7. Period 3: single dose of SSD8432 dose 3 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date Cohort 2: Period 1 single dose of SSD8432 dose 4 or placebo, on day 1 Period 2: single doses of SSD8432 dose 5 or placebo , on day 7 Period 3: single dose of SSD8432 dose 6 on day 13, ritonavir or placebo, before SSD8432 dose 3 and BID on SSD8432 dosing date Cohort 3: single dose of SSD8432 dose 7 or placebo on day1. ritonavir or placebo, before SSD8432 dose 7 and BID on SSD8432 dosing date. |
| Measure | Description | Time Frame |
|---|---|---|
| The Adverse events of SSD8432(Part A~D) | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) | From signing ICF up to day 26 |
| PK parameters(Part E) | Time for Cmax (Tmax) | Day 1 to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters(Part A~D) | Time for Cmax (Tmax) | Day 1 to Day 4 |
| The Adverse events of SSD8432(Part E) | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lily Chen | Contact | +86 025-85566666 | chenlihua2@simcere.com |
| Name | Affiliation | Role |
|---|---|---|
| Yumei Yang | Jiangsu Simcere Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 250014 | 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. | |
| 37783378 |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
| SSD8432 dose 8~9 | Drug | Cohort 4: SSD8432 dose 8 or placebo, on day 1 ~day6. Cohort 5: SSD8432 dose 9 or placebo, on day 1 ~day6. |
|
| SSD8432 dose 10~12 and ritonavir | Drug | Cohort 6: SSD8432 dose 10 or placebo, on day 1 ~day6. Cohort 7: SSD8432 dose 11 or placebo, on day 1 ~day6. Cohort 8: SSD8432 dose 12 or placebo, on day 1 ~day6 Cohort 9: to be decided |
|
| SSD8432 dose 13 and Ritonavir | Drug | Cohort 10: Group A: SSD8432 dose 13, on day1 under fasting condition, on day 6 under fatty food condition, ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date. Group B: SSD8432 dose 13, on day1 fatty food condition, on day 6 under fasting condition ,Ritonavir, before SSD8432 dose 13 and BID on SSD8432 dosing date |
|
| SSD8432 dose 14 and Ritonavir | Drug | Cohort 11: to be decided |
|
| From signing ICF up to day 26 |
| Derived |
| 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. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |