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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06435936 | A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo | PHASE1 | ACTIVE NOT_RECRUITING | 28 | — | — | Apr 22, 2024 | Feb 1, 2025 | Sep 19, 2024 | 1 | United States |
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...