A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants

Insmed

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: INS1007

Study type: Interventional

Funder types: Industry

Identifiers

NCT05927597

INS1007-101

Details and patient eligibility

About

The primary purpose of Part A of this study is to compare, in a single dose and multiple doses the safety, tolerability, and pharmacokinetics (PK) profile administered in Japanese and Caucasian participants and of Part B of the study is to assess the food effect of a single dose of INS1007 administered in Japanese and Caucasian participants.

Enrollment: 82 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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: Participants must be of Caucasian descent, as evidenced by verbal confirmation that all four grandparents are Caucasian.
• Healthy, based on pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations) by the PI or designee.

Exclusion criteria

• Have clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the PI or designee.
• Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to Screening. Examples may include, but are not limited to, infections requiring intravenous (IV) antibiotics, hospitalization, or prolonged (>14 day) anti-infective treatment.
• Have a history of multiple or severe allergies, or an anaphylactic reaction, to prescription or non-prescription drugs or food.
• Have a positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antigen or antibody at the Screening Visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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82 participants in 5 patient groups

Part A: Cohort 1 (Dose 1)

Experimental group

Description:

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.

Treatment:

Drug: INS1007

Drug: Placebo

Part A: Cohort 2 (Dose 2)

Experimental group

Description:

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.

Treatment:

Drug: INS1007

Drug: Placebo

Part A: Cohort 3 (Dose 3)

Experimental group

Description:

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.

Treatment:

Drug: INS1007

Drug: Placebo

Part B: Treatment Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: INS1007

Part B: Treatment Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: INS1007