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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07345364 | A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants | PHASE1 | RECRUITING | 72 | — | — | Jan 12, 2026 | Aug 31, 2026 | May 20, 2026 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| SIM0811 | EXPERIMENTAL | The study is designed to include 6 dose groups across 9 cohorts, with two administration methods: intravenous bolus plus intravenous infusion, and intravenous bolus alone. Each cohort will enroll 6 participants to receive SIM0811 The study will employ a dose-escalation design starting from Cohort 1. After administration in each dose group/cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC) |
| Placebo | PLACEBO_COMPARATOR | The study is designed to include 7 dose groups across 9 cohorts, with two administration methods: intravenous bolus plus intravenous infusion, and intravenous bolus alone. Each cohort will enroll 2 participants to receive placebo The study will employ a dose-escalation design starting from Cohort 1. After administration in each dose group/cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC) |
| Name | Type | Description |
|---|---|---|
| SIM0811 | DRUG | The study will employ a dose-escalation design starting from Cohort 1. Each cohort will receive a single administration, sequentially completing Cohort 2, Cohort 3, Cohort 4, Cohort 5 , Cohort 6, Cohort 7,Cohort 8 and Cohort 9. After administration in each cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC). |
| Placebo | DRUG | The study will employ a dose-escalation design starting from Cohort 1. Each cohort will receive a single administration, sequentially completing Cohort 2, Cohort 3, Cohort 4, Cohort 5 , Cohort 6, Cohort 7 Cohort 8and Cohort 9. After administration in each cohort, participants will be observed for 7 days for safety evaluation. Provided no stopping criteria are met, escalation to the next dose level may proceed only after review by the Safety Review Committee (SRC). |
Inclusion Criteria: 1. Healthy Chinese male or female adults aged 18 to 45 years (inclusive), not pregnant and not breastfeeding. 2. Male participants weight ≥50 kg, female participants weight ≥45 kg, all ≤90 kg. Body Mass Index (BMI) between 19 and 26 kg/m² (inclusive). BMI = weight (kg) / height²...