drugset / Trial / NCT05456490
Phase 1, Dose Escalation Study to Evaluate of Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered Via a Single Intrathecal Injection to Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
Summary
Primary Objective: To assess the safety and tolerability of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers. Secondary Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers.
Timeline
- Start
- 2023-04-18
- Primary completion
- 2025-02-27
- Completion
- 2025-02-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 15 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 26.6 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 39.9 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 53.2 mg | Intrathecal |
Indications
No indication recorded.