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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03974776 | Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants | PHASE1 | COMPLETED | 8 | — | — | Jul 8, 2019 | Jan 10, 2020 | Jan 29, 2020 | 1 | United States |
| NCT03599063 | Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects | PHASE1 | COMPLETED | 63 | — | — | Jul 30, 2018 | Sep 18, 2019 | Nov 8, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| PF-06946860 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 |
| Placebo | PLACEBO_COMPARATOR | Single subcutaneous administration of placebo |
| Cohort 1 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo |
| Cohort 2 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo |
| Cohort 3 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo |
| Cohort 4 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo |
| Cohort 5 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo |
| Cohort 6 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo |
| Cohort 7 | EXPERIMENTAL | Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo |
| Optional: Cohort 8 | EXPERIMENTAL | Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects |
| Name | Type | Description |
|---|---|---|
| PF-06946860 | BIOLOGICAL | PF-06946860 administered subcutaneously |
| Placebo | OTHER | Placebo administered subcutaneously |
Key Inclusion Criteria: * Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive * Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) * Evidence of a personall...