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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05877053 | A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants | PHASE1 | COMPLETED | 102 | — | — | May 9, 2023 | Nov 20, 2024 | May 1, 2025 | 1 | United States |
To assess the safety and tolerability of CK-4021586 when administered orally as single or multiple doses to healthy participants
| Arm | Type | Description |
|---|---|---|
| CK-4021586 for SAD Cohort | EXPERIMENTAL | Subjects will be assigned to one of 8 planned dose cohorts and receive single doses of CK-4021586 |
| Placebo for SAD Cohort | PLACEBO_COMPARATOR | Subjects will be assigned to one of approximately 8 planned cohorts and receive single doses of placebo |
| CK-4021586 for MAD Cohort | EXPERIMENTAL | Subjects will be assigned to one of 4 planned dose cohorts and receive multiple doses of CK-4021586 |
| Placebo for MAD Cohort | PLACEBO_COMPARATOR | Subjects will be assigned to one of approximately 4 planned cohorts and receive multiple of placebo |
| Food Effect | EXPERIMENTAL | Healthy subjects will be administered CK-4021586 with and without food in a cross-over fashion |
| Name | Type | Description |
|---|---|---|
| CK-4021586 | DRUG | CK-4021586 |
| Placebo for CK-4021586 | DRUG | Placebo for CK-4021586 |
Inclusion Criteria: * Healthy male and female participants aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg Exclusion Criteria: * Significant history or clinical manifestation of any significant metabolic, aller...