- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05927597
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants
June 22, 2023 updated by: Insmed Incorporated
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- USA001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
Oral tablets.
Other Names:
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.
|
Oral tablets.
Other Names:
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.
|
Oral tablets.
Other Names:
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.
|
Oral tablets.
Other Names:
|
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.
|
Oral tablets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE)
Time Frame: 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.
|
Up to Day 61 in Part A and up to Day 11 in Part B
|
Parts A and B: Area Under the Plasma Concentration-time Curve (AUC) of INS1007
Time Frame: 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.
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood
Time Frame: 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.
|
Up to Day 61
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2019
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 1, 2019
Study Registration Dates
First Submitted
June 22, 2023
First Submitted That Met QC Criteria
June 22, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 22, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- INS1007-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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