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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05927597 | A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants | PHASE1 | COMPLETED | 82 | — | — | Jan 9, 2019 | Aug 1, 2019 | Jul 3, 2023 | 1 | United States |
Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants.
Comparison of the pharmacokinetics of single and multiple doses of INS1007 in Japanese and Caucasian participants.
| Arm | Type | Description |
|---|---|---|
| Part A: Cohort 1 (Dose 1) | EXPERIMENTAL | Japanese and Caucasian participants will receive INS1007 at Dose 1 or matching placebo, orally, once on Day 1, and Day 4 through Day 30 in Part A under fasted conditions. |
| Part A: Cohort 2 (Dose 2) | EXPERIMENTAL | Japanese and Caucasian participants will receive INS1007 at Dose 2 or matching placebo, orally, once on Day 1, and Day 4 through Day 30 in Part A under fasted conditions. |
| Part A: Cohort 3 (Dose 3) | EXPERIMENTAL | Japanese and Caucasian participants will receive INS1007 at Dose 3 or matching placebo, orally, up to Day 30 in Part A under fasted conditions. Enrollment will commence in this cohort once the safety and tolerability data in Cohort 2 is deemed acceptable by the principal investigator (PI) and the Sponsor's medical monitor. |
| Part B: Treatment Sequence 1 | EXPERIMENTAL | Japanese and Caucasian participants will receive INS1007 at the dose established in Part A after a high-fat and high-calorie breakfast on Day 1 followed by a dose established in Part A on Day 8 under fasted conditions in Part B of the study. |
| Part B: Treatment Sequence 2 | EXPERIMENTAL | Japanese and Caucasian participants will receive INS1007 at the dose established in Part A under fasted conditions on Day 1 followed by dose established in Part A on Day 8 after a high-fat and high-calorie breakfast in Part B of the study. |
| Name | Type | Description |
|---|---|---|
| INS1007 | DRUG | Oral tablets. |
| Placebo | DRUG | Oral tablets. |
Inclusion Criteria: * For Japanese participants: Participant is of Japanese descent as evidenced by verbal confirmation of familial heritage (a participant must have all four grandparents born in Japan). Participants must have lived less than 10 years outside of Japan. * For Caucasian participants:...