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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | COMPLETED | 54 | — | — | Apr 18, 2023 | Feb 27, 2025 | Mar 17, 2025 | 1 | United States |
Pharmacokinetic Endpoint
Pharmacokinetic Endpoint
Pharmacokinetic Endpoint
Pharmacokinetic Endpoint
Pharmacokinetic Endpoint
Pharmacokinetic Endpoint
| Arm | Type | Description |
|---|---|---|
| Liposomal Bupivacaine 13.3 | EXPERIMENTAL | Cohort 1 subjects will be dosed 2 mL (26.6 mg) of Liposomal Bupivacaine 13.3. Cohort 2 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 3 mL (39.9 mg) of Liposomal Bupivacaine 13.3. Cohort 3 subjects randomized to the Liposomal Bupivacaine 13.3 arm will be dosed 4 mL (53.2 mg) of Liposomal Bupivacaine 13.3. |
| Bupivacaine IT | ACTIVE_COMPARATOR | Cohort 1 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine. Cohort 2 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg/ 1 mL) of 0.75% bupivacaine mixed with 1 mL of preservative free normal saline to create a total volume of solution administered of 3 mL. Cohort 3 subjects randomized to the bupivacaine arm will be dosed 2 mL (7.5 mg / 1 mL) of 0.75% bupivacaine mixed with 2 mL of preservative free normal saline to create a total volume of solution administered of 4 mL. |
| Placebo | PLACEBO_COMPARATOR | Cohort 1 subjects randomized to the placebo arm will be dosed 2 mL of preservative free normal saline. Cohort 2 subjects randomized to the placebo arm will be dosed 3 mL of preservative free normal saline. Cohort 3 subjects randomized to the placebo arm will be dosed 4 mL of preservative free normal saline. |
| Name | Type | Description |
|---|---|---|
| Liposomal Bupivacaine 13.3 | DRUG | Injection into the Intrathecal space |
| Bupivacaine | DRUG | Injection into the Intrathecal space |
| Placebo | OTHER | Injection into the Intrathecal space |
Inclusion Criteria: 1. Healthy adult male or female volunteers ages ≥18 and ≤50 years old. 2. American Society of Anesthesiologists physical status 1 3. Able to provide informed consent, adhere to the study schedule, and complete all study assessments. Exclusion Criteria: 1. Allergy, hypersensiti...