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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05102552 | Evaluating the Safety and Relative Bioavailability of Three SPN-817 Treatments (A, B and C) in Healthy Adult Subjects | EARLY_PHASE1 | COMPLETED | 30 | — | — | Oct 19, 2021 | Aug 15, 2022 | Aug 30, 2022 | 1 | Australia |
Area under the curve (AUC)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | ACTIVE_COMPARATOR | BIS-001: Treatment A and SPN-817: Treatment B |
| Cohort 2 | ACTIVE_COMPARATOR | BIS-001: Treatment A and SPN-817: Treatment C |
| Name | Type | Description |
|---|---|---|
| SPN-817, Treatment B | DRUG | SPN-817 Treatment B, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor |
| SPN-817, Treatment C | DRUG | SPN-817 Treatment C, is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor |
| BIS-001, Treatment A | DRUG | BIS-001 is an Extended Release formulation of Huperzine A, an acetylcholinesterase inhibitor |
Inclusion Criteria 1. Healthy adult male or female volunteers, 18-55 years of age inclusive. 2. Weight of at least 50 kg and within the normal Body Mass Index (BMI) between 18 - 32 kg/m2 (inclusive). 3. Considered medically healthy by the Investigator via assessment of physical and neurological exa...