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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02982889 | Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations | PHASE1 | COMPLETED | 29 | — | — | Dec 5, 2016 | Apr 26, 2017 | Aug 24, 2017 | 1 | Denmark |
Safety assessments will include the incidence and severity of AEs during treatment and the follow-up period of the study
| Arm | Type | Description |
|---|---|---|
| LIQ865A bupivacaine formulation | EXPERIMENTAL | Liquidia's PRINT bupivacaine free base/PLGA (poly D,L-lactic-co-glycolic acid) suspension for subcutaneous injection at doses ranging from 150mg to 600mg |
| LIQ865B bupivacaine formulation | EXPERIMENTAL | Liquidia's PRINT bupivacaine free base suspension for subcutaneous injection at doses ranging from 150mg to 600mg |
| Diluent for LIQ865 | PLACEBO_COMPARATOR | Negative control for subcutaneous injection. Each subject will act as his own control, receiving a LIQ865 formulation subcutaneous injection in one calf, and a diluent subcutaneous injection in his other calf |
| 0.5% bupivacaine hydrochoride | ACTIVE_COMPARATOR | Positive control arm to be used with one of the LIQ865 cohorts, with each subject acting as his own positive control (i.e., one leg will receive subcutaneous injection of LIQ865A or LIQ865B, and the other leg will receive subcutaneous injection of 0.5% bupivacaine hydrochloride). |
| Name | Type | Description |
|---|---|---|
| LIQ865A bupivacaine formulation | DRUG | single subcutaneous injection in medial calf |
| LIQ865B bupivacaine formulation | DRUG | single subcutaneous injection in medial calf |
| Diluent for LIQ865 | DRUG | Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection |
| 0.5% bupivacaine hydrochoride | DRUG | single subcutaneous injection |
Inclusion Criteria: * provide written informed consent prior to enrollment * be a non-smoking male, American Society of Anesthesiologist (ASA) physical class 1 or 2 * have a BMI between 18.5 and 25 kg. inclusive, and a weight of at least 60 kg * be willing and able to participate for the duration o...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |