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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06063291 | Single Ascending Oral Dose Phase 1 Study of ID110521156 in Healthy Adult Subjects | PHASE1 | COMPLETED | 36 | — | — | Nov 20, 2023 | Jul 11, 2024 | Nov 25, 2024 | 1 | South Korea |
Incidence and severity of ad adverse event
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
| Cohort 2 | EXPERIMENTAL | Cohort 2 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
| Cohort 3 | EXPERIMENTAL | Cohort 3 will consist of 8 healthy subjects who will be randomised to receive a single oral dose of ID110521156 of placebo. |
| Cohort 4 | EXPERIMENTAL | Cohort 4 will consist of 12 healthy subjects who will receive a single oral dose of ID110521156 at fed state and fasted state each. |
| Name | Type | Description |
|---|---|---|
| ID110521156 | DRUG | subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1 |
| Placebo of ID110521156 | DRUG | subjects will receive a single oral dose of IMP. In the morning (all procedures must be performed at the similar clock time) on Day 1 |
Inclusion Criteria: * Healthy subjects aged 19 to 50 years at the time of Screening. * Body mass index (BMI) within 18.5 to 29.9 kg/m2; and a total body weight ≥ 40 kg, ≤ 90 kg * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all...