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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05579431 | A Phase 1, First-in-human Study of VX-634 | PHASE1 | COMPLETED | 127 | — | — | Oct 13, 2022 | Nov 13, 2023 | Mar 12, 2024 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Participants grouped in different cohorts will receive a single ascending dose of VX-634. |
| Placebo Part A | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-634. |
| Part B | EXPERIMENTAL | Participants grouped in different cohorts will receive multiple doses of VX-634.The dose levels will be determined based on the data from Part A. |
| Placebo Part B | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-634. |
| Name | Type | Description |
|---|---|---|
| VX-634 | DRUG | Suspension for oral administration. |
| Placebo | DRUG | Suspension for oral administration. |
Key Inclusion Criteria: * Participants of age between 18 to 55 years (inclusive) * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>)50 kg * Participants of non childbearing potential * Non smoker or ex-smoker for at least 3 months befo...