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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07487545 | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion | PHASE1 | NOT YET_RECRUITING | 52 | — | — | Mar 31, 2026 | Apr 2, 2027 | Mar 23, 2026 | 2 | Australia, China |
| Arm | Type | Description |
|---|---|---|
| SSS67 1mg/kg | EXPERIMENTAL | This is a single-dose group. 2 participants will be enrolled and receive a single intravenous infusion of SSS67 at 1 mg/kg on Day 1. No placebo is administered in this group. |
| SSS67 5mg/kg+Placebo | EXPERIMENTAL | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 5 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 15mg/kg+Placebo | EXPERIMENTAL | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 15 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 30mg/kg+Placebo | EXPERIMENTAL | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 30 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 45mg/kg+Placebo | EXPERIMENTAL | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 45 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 60mg/kg+Placebo | EXPERIMENTAL | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 60 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| SSS67 Injection | DRUG | In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. |
| Placebo | DRUG | Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
Inclusion Criteria: * Participants aged 18 to 65 years (inclusive), regardless of gender. * Participate in the clinical trial voluntarily and provide informed consent form. * At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females. Body Mass Index (BMI) must be between 18.5 and 32 kg/m²...