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

Sponsor
Insmed Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT05927597
Collaborator
(none)
82
Enrollment
1
Location
5
Arms
6.7
Actual Duration (Months)
12.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses and the Open-Label Food Effect of a Single Dose of INS1007 in Healthy Japanese and Caucasian Subjects
Actual Study Start Date :
Jan 9, 2019
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A: Cohort 1 (Dose 1)

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.

Drug: INS1007
Oral tablets.
Other Names:
  • AZD7986
  • Brensocatib

    • Drug: Placebo
    Oral tablets.
    Experimental: Part A: Cohort 2 (Dose 2)

    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.

    Drug: INS1007
    Oral tablets.
    Other Names:
  • AZD7986
  • Brensocatib

    • Drug: Placebo
    Oral tablets.
    Experimental: Part A: Cohort 3 (Dose 3)

    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.

    Drug: INS1007
    Oral tablets.
    Other Names:
  • AZD7986
  • Brensocatib

    • Drug: Placebo
    Oral tablets.
    Experimental: Part B: Treatment Sequence 1

    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.

    Drug: INS1007
    Oral tablets.
    Other Names:
  • AZD7986
  • Brensocatib

    		•
    Experimental: Part B: Treatment Sequence 2

    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.

    Drug: INS1007
    Oral tablets.
    Other Names:
  • AZD7986
  • Brensocatib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE) [Up to Day 61 in Part A and up to Day 11 in Part B]

      Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants.

    2. Parts A and B: Area Under the Plasma Concentration-time Curve (AUC) of INS1007 [Part A: Predose and at multiple time points postdose up to Day 33; Part B: Predose and at multiple time points postdose up to Day 11]

      Comparison of the pharmacokinetics of single and multiple doses of INS1007 in Japanese and Caucasian participants.

    Secondary Outcome Measures

    1. Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood [Up to Day 61]

      Pharmacodynamic activity based on concentration of biomarkers cathepsin G (Cat G), proteinase 3 (PR3), neutrophil elastase (NE), and absolute neutrophil in blood will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USA001 Glendale California United States 91206

    Sponsors and Collaborators

    • Insmed Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Insmed Incorporated
    ClinicalTrials.gov Identifier:
    NCT05927597
    Other Study ID Numbers:
    • INS1007-101
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 3, 2023