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INS1007 · 1 trial · 1 indication
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:...
INS1007 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is currently in clinical development to evaluate its safety, pharmacokinetics, and pharmacodynamics. The drug is being developed by Insmed Incorporated.
INS1007 is being developed by Insmed Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker INSM. The company is conducting clinical trials to evaluate the drug's safety and pharmacological profile in healthy participants.
INS1007 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, involving 82 healthy participants. The drug is investigational and has not been approved by regulatory authorities.
INS1007 has one completed Phase 1 clinical trial registered as NCT05927597. The study evaluated the safety, pharmacokinetics, and pharmacodynamics of INS1007 in healthy Japanese and Caucasian participants in the United States. The trial enrolled 82 participants.
INS1007 is the primary name for this investigational drug. No alternative names have been disclosed in the clinical trial information. The drug is being studied under this identifier in its Phase 1 clinical program.