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SNA02-48 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| SNA02-48 | EXPERIMENTAL | If randomized to SNA02-48, participant will receive a single IM gluteal injection of SNA02-48 |
| Human tetanus immunoglobulin (HTIG) | ACTIVE_COMPARATOR | If randomized to HTIG, participant will receive a single IM gluteal injection of HTIG |
| 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 | DRUG | IM gluteal injection |
| Human tetanus immunoglobulin (HTIG) | DRUG | IM gluteal injection |
| Placebo | BIOLOGICAL | intramuscular injection |
| HTIG | BIOLOGICAL | intramuscular injection |
| Tetanus Toxoid | BIOLOGICAL | intramuscular injection |
Inclusion Criteria: 1. Males or females aged 18 years and above; 2. Participants who can understand and voluntarily sign the informed consent form; 3. Participants with high-risk tetanus exposure; 4. Participants of childbearing potential and their sexual partners voluntarily adopt effective contra...
SNA02-48 is an investigational monoclonal antibody being developed for tetanus, an infectious disease. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities. The drug is being studied in adult participants in China.
SNA02-48 is being developed by Sinovac Biotech, Ltd, a biopharmaceutical company listed on the stock exchange under the ticker SVA. The company is conducting clinical trials for this investigational monoclonal antibody in China.
SNA02-48 is in Phase 3 clinical development for tetanus. A Phase 1 study has been completed, and a Phase 3 trial is planned but has not yet started recruiting participants. The drug remains investigational and has not been approved.
SNA02-48 has been studied in two clinical trials. A completed Phase 1 trial, NCT06939777, evaluated safety and pharmacokinetics in 255 healthy Chinese adults. A Phase 3 trial, NCT07633119, is planned with 600 participants and is not yet recruiting.
SNA02-48 is a monoclonal antibody, which is a type of protein designed to bind to a specific target in the body. For tetanus, the antibody is intended to neutralize the toxin that causes the disease. The exact molecular target has not been disclosed.
SNA02-48 is the name used in clinical trials for this investigational monoclonal antibody. No alternative names have been reported for this drug. It is being studied under this name in trials registered with ClinicalTrials.gov.