drugset / Trial / NCT04711005
Phase 1 Evaluation of (2R,6R)-Hydroxynorketamine
RandomizedSequentialDouble-blindTreatment
Summary
A 6-cohort single ascending dose (SAD) study will be conducted in healthy volunteers utilizing a slow-infusion intravenous (IV) route of administration. Standard safety, pharmacokinetics (PK) and qEEG monitoring will be evaluated at all dose levels. Subsequently, a 2-cohort multiple ascending dose (MAD) study will be conducted. Doses will be administered on days 1, 4, 8, and 11. Standard safety parameters will be monitored, and PK will be evaluated at all dose levels. Finally, a single-cohort group with received a single dose by slow-infusion IV and have PK samples collected from both blood and cerebrospinal fluid (CSF).
Timeline
- Start
- 2021-01-11
- Primary completion
- 2023-04-30
- Completion
- 2023-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | (2R,6R)-hydroxynorketamine | Small molecule | 0.1 mg/kg | Intravenous |
| Subject | (2R,6R)-hydroxynorketamine | Small molecule | 0.25 mg/kg | Intravenous |
| Subject | (2R,6R)-hydroxynorketamine | Small molecule | 0.5 mg/kg | Intravenous |
| Subject | (2R,6R)-hydroxynorketamine | Small molecule | 1 mg/kg | Intravenous |
| Subject | (2R,6R)-hydroxynorketamine | Small molecule | 2 mg/kg | Intravenous |
| Subject | (2R,6R)-hydroxynorketamine | Small molecule | 4 mg/kg | Intravenous |