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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04037657 | Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Female Subjects. | PHASE1 | COMPLETED | 25 | — | — | Apr 22, 2015 | Nov 13, 2015 | Jul 31, 2019 | - | — |
Observe the change of modified observer's assessment of alert /sedation during the whole trial
| Arm | Type | Description |
|---|---|---|
| HSK3486 | EXPERIMENTAL | 0.288 mg/kg ，0.432 mg/kg ，0.540 mg/kg ，0.648 mg/kg，0.810 mg/kg There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol). |
| Propofol | ACTIVE_COMPARATOR | 2.5 mg propofol |
| Name | Type | Description |
|---|---|---|
| HSK3486 | DRUG | HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol). |
| Propofol | DRUG | Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump. |
Inclusion Criteria: * Female, aged 18 - 49 years (inclusive) * Women of child-bearing potential agreed to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy * Negative serum pregnancy test * In general good healt...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Masimo Corporation | MASI | 1 | PHASE1 | Diprivan , Astra-Zeneca |
| Cardinal Health, Inc. | CAH | 1 | — | Undisclosed |
| Medtronic Plc | MDT | 1 | NA | Undisclosed |