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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04876924 | A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers | PHASE1 | COMPLETED | 92 | — | — | Apr 29, 2021 | Feb 27, 2022 | Mar 21, 2022 | 1 | United States |
Incidence of Adverse Events (AEs)
| Arm | Type | Description |
|---|---|---|
| BBP-711 for SAD | EXPERIMENTAL | A single dose of BBP-711 will be administered orally. |
| Placebo for SAD | PLACEBO_COMPARATOR | A single dose of matching placebo will be administered orally. |
| BBP-711 for MAD | EXPERIMENTAL | A dose of BBP-711 will be administered orally for multiple days. |
| Placebo for MAD | PLACEBO_COMPARATOR | A dose of matching placebo will be administered orally for multiple days. |
| BBP-711 for SAD Food Effect | EXPERIMENTAL | A single dose of BBP-711 will be administered orally. |
| Placebo for SAD Food Effect | PLACEBO_COMPARATOR | A single dose of matching placebo will be administered orally. |
| Name | Type | Description |
|---|---|---|
| BBP-711 | DRUG | BBP-711, oral suspension |
| Placebo | DRUG | Placebo matching BBP-711 |
Inclusion Criteria: * Adult male or female who is 18 to 65 years old, * Weight \>50 kg and ≤110 kg at Screening * Body mass index (BMI) 20 to 32 kg/m2, inclusive, at Screening * In generally good health * Nonsmoker, or not using tobacco or nicotine-containing products for at least 6 months Exclusi...