Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Single Ascending Dose of SAB-176 · 1 trial · 1 indication
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
| Arm | Type | Description |
|---|---|---|
| SAB-176 1 mL | EXPERIMENTAL | 1 mL (\~75 mg) SAB-176 dose |
| Placebo 1mL | PLACEBO_COMPARATOR | Normal Saline |
| SAB-176 3mL | EXPERIMENTAL | 3 mL (\~225 mg) SAB-176 dose |
| Placebo 3mL | PLACEBO_COMPARATOR | Normal Saline |
| SAB-176 5mL | EXPERIMENTAL | 5 mL (\~375 mg) SAB-176 dose |
| Placebo 5mL | PLACEBO_COMPARATOR | Normal Saline |
| SAB-176 20mL | EXPERIMENTAL | 20 mL (\~1500 mg) SAB-176 dose |
| Placebo 20mL | PLACEBO_COMPARATOR | Normal Saline |
| Name | Type | Description |
|---|---|---|
| Single Ascending Dose of SAB-176 | DRUG | Single ascending dose |
| Single Ascending Dose of Placebo | DRUG | Single ascending dose |
Inclusion Criteria: * 1\. Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment. 2\. Completion and review of assessment of understanding test (achieved \> 70% accuracy). 3\. Signed informed consent document. 4. Available for the required follow-up period an...
SAB-176 is an investigational therapy being studied for the prevention of influenza, specifically in the condition PHA1A. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial to assess its safety when given intramuscularly in healthy adults.
SAB-176 is being developed by SAB Biotherapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SABS. The company is conducting a Phase 1 clinical trial to evaluate the safety of SAB-176 for the prevention of influenza in healthy adult participants.
SAB-176 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by the FDA. The ongoing Phase 1 trial is designed to assess the safety of SAB-176 when administered intramuscularly to healthy adults compared with placebo.
SAB-176 is being studied in one active clinical trial with the identifier NCT06435936. This Phase 1 study is titled 'A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo.' The trial is active but not recruiting participants and has an enrollment of 28 healthy volunteers in the United States.
SAB-176 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The FDA has granted SAB-176 Fast Track and Breakthrough Therapy designations, which are intended to expedite the development and review of drugs that treat serious conditions and fill unmet medical needs.
Yes, SAB-176 is classified as a small molecule therapeutic. It is being developed for the prevention of influenza in the rare disease area, specifically for the condition PHA1A. The drug is administered intramuscularly and is currently being evaluated in a Phase 1 clinical trial.