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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02794740 | Study of X0002 Following Escalating Single and Multiple Doses Administered as Topical Application in Healthy Volunteers | PHASE1 | COMPLETED | 34 | — | — | Jun 1, 2016 | Mar 29, 2017 | Sep 12, 2018 | 1 | China |
Adverse Event; Vital Signs; Physical Examination; Laboratory Examination; Electrocardiograph; Skin Irritation
| Arm | Type | Description |
|---|---|---|
| X0002 First Dose | EXPERIMENTAL | Preliminary Experiment,4 Subjects,Single-Dose,Once,Non-Blind. |
| X0002 Second Dose | EXPERIMENTAL | 8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| Placebo Second Dose | PLACEBO_COMPARATOR | 2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| X0002 Third Dose | EXPERIMENTAL | 8 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| Placebo Third Dose | PLACEBO_COMPARATOR | 2 Subjects,Single Dose once and Multiple Doses 7 Days,b.i.d,12 Hours Apart,Double-Blind. |
| X0002 Fourth Dose | EXPERIMENTAL | 8 Subjects,Single Dose,Once,Double-Blind. |
| Placebo Fourth Dose | PLACEBO_COMPARATOR | 2 Subjects,Single Dose,Once,Double-Blind. |
| Name | Type | Description |
|---|---|---|
| X0002 | DRUG | External Spray |
| Placebo | DRUG | External Spray |
Inclusion Criteria: * Gender: male or female, each sex ratio does no less 1/3; * Were between the ages of 18 and 45 years, inclusive. General condition is will; * Were between the Body Mass Index (BMI) of 19-28, inclusive; BMI=Weight(kg)/Height2 (m2); Weight≥50kg (female) and 60kg (male); * Nearly ...