Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05523739 | Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients | PHASE1 | COMPLETED | 79 | — | — | Sep 16, 2022 | Mar 29, 2023 | Aug 14, 2023 | 1 | China |
Incidence and severity of AEs up to 6 days for part 1 and 21 days for part 2 post-dosing.
| Arm | Type | Description |
|---|---|---|
| Part 1: Cohort 1 | EXPERIMENTAL | Participants will receive a single 300 mg dose of STI-1558 or placebo. Cohort 1 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 1: Cohort 2 | EXPERIMENTAL | Participants will receive a single 600 mg dose of STI-1558 or placebo. Cohort 2 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 1: Cohort 3 | EXPERIMENTAL | Participants will receive a single 1200 mg dose of STI-1558 or placebo. Cohort 3 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 1: Cohort 4 | EXPERIMENTAL | Participants will receive a single 2000 mg dose of STI-1558 or placebo. Cohort 4 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 2: Cohort 1 | EXPERIMENTAL | Participants will receive a 300 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses. Cohort 1 will dose 6 subjects to STI-1558 and 2 subjects to placebo. |
| Part 2: Cohort 2 | EXPERIMENTAL | Participants will receive a 600 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses. Cohort 2 will dose 16 subjects to STI-1558 and 8 subjects to placebo. |
| Part 2: Cohort 3 | EXPERIMENTAL | Participants will receive a 800 mg dose of STI-1558 or placebo q12h on Day1 to Day7 and once in the morning on Day8 for a total of 15 doses. Cohort 3 will dose 16 subjects to STI-1558 and 8 subjects to placebo. |
| Name | Type | Description |
|---|---|---|
| STI-1558 | DRUG | An oral small molecule prodrug that effectively inhibits the SARS-CoV-2 main protease (Mpro). |
Inclusion Criteria: * Part 1 1. Subjects are fully informed of the study and sign the informed consent document prior to any procedure. 2. Healthy subjects aged ≥18 but ≤45 years old, regardless of gender. 3. BMI ≥18, but ≤30kg/m2, and weight ≥45, but ≤100kg. 4. Good health status, with no...