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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06939777 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants | PHASE1 | COMPLETED | 255 | — | — | Apr 28, 2025 | Mar 30, 2026 | Jun 3, 2026 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| Cohort 1:low-dose SNA02-48/placebo (Phase I) | EXPERIMENTAL | Participants will be randomly assigned to receive either low-dose SNA02-48 or placebo. |
| Cohort 2: medium-dose SNA02-48/placebo (Phase I) | EXPERIMENTAL | Participants will be randomly assigned to receive either medium-dose SNA02-48 or placebo. |
| Cohort 3: high-dose SNA02-48/placebo (Phase I) | EXPERIMENTAL | Participants will be randomly assigned to receive either high-dose SNA02-48 or placebo. |
| Group A :low-dose SNA02-48 + placebo (Phase II) | EXPERIMENTAL | Participants will receive a single intramuscular (IM) gluteal injection of low-dose SNA02-48 and a single IM deltoid injection of placebo |
| Group B : medium-dose SNA02-48 + placebo (Phase II) | EXPERIMENTAL | Participants will receive a single IM gluteal injection of medium-dose SNA02-48 and a single IM deltoid injection of placebo |
| Group C : high-dose SNA02-48 + placebo (Phase II) | EXPERIMENTAL | Participants will receive a single IM gluteal injection of high-dose SNA02-48 and a single IM deltoid injection of placebo |
| Group D : low-dose SNA02-48 + Tetanus Toxoid (Phase II) | EXPERIMENTAL | Participants will receive a single IM gluteal injection of low-dose SNA02-48 and a single IM deltoid injection of Tetanus Toxoid（TT） |
| Group E : medium-dose SNA02-48 + Tetanus Toxoid (Phase II) | EXPERIMENTAL | Participants will receive a single IM gluteal injection of medium-dose SNA02-48 and a single IM deltoid injection of Tetanus Toxoid（TT） |
| Group F : high-dose SNA02-48 + Tetanus Toxoid (Phase II) | EXPERIMENTAL | Participants will receive a single IM gluteal injection of high-dose SNA02-48 and a single IM deltoid injection of Tetanus Toxoid（TT） |
| Group G : placebo + Tetanus Toxoid (Phase II) | PLACEBO_COMPARATOR | Participants will receive a single IM gluteal injection of placebo and a single IM deltoid injection of Tetanus Toxoid（TT） |
| Group H : Human tetanus immunoglobulin(HTIG) + placebo (Phase II) | ACTIVE_COMPARATOR | Participants will receive a single IM gluteal injection of Human tetanus immunoglobulin(HTIG) and a single IM deltoid injection of placebo |
| Group I : Human tetanus immunoglobulin(HTIG) + Tetanus Toxoid（TT） (Phase II) | ACTIVE_COMPARATOR | Participants will receive a single IM gluteal injection of Human tetanus immunoglobulin(HTIG) and a single IM deltoid injection of Tetanus Toxoid（TT） |
| Name | Type | Description |
|---|---|---|
| SNA02-48 | BIOLOGICAL | intramuscular injection |
| Placebo | BIOLOGICAL | intramuscular injection |
| HTIG | BIOLOGICAL | intramuscular injection |
| Tetanus Toxoid | BIOLOGICAL | intramuscular injection |
Inclusion Criteria: 1. Male or female, 18-59 years of age； 2. Participants have the ability to understand and agree to sign the informed consent form； 3. Male participants with a weight of≥50.0kg; Female participants with a weight of ≥ 45.0kg and the weight of both men and women≤90 kg, 18.5 kg/m2≤B...