Healthy VolunteersPhase 1NCT05927597
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants
A Phase 1 study testing INS1007 in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- INS1007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 1 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- INS1007, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS1007Drug
Also called AZD7986, Brensocatib
Oral tablets.
PlaceboDrug
Oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: INS1007; Drug: Placebo |
| 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. Receives: Drug: INS1007; Drug: Placebo |
| 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. Receives: Drug: INS1007; Drug: Placebo |
| 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. Receives: Drug: INS1007 |
| 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. Receives: Drug: INS1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Number of Participants Who Experienced at Least One Adverse Event (AE)
Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants.
Measured: 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
Comparison of the pharmacokinetics of single and multiple doses of INS1007 in Japanese and Caucasian participants.
Measured: 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 outcomes (1)
Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood
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.
Measured: Up to Day 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start9 Jan 2019
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927597
- Sponsor's protocol ID
- INS1007-101
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Usansky H, Yoon E, Teper A, Zou J, Fernandez C. Safety, Tolerability, and Pharmacokinetic Evaluation of Single and Multiple Doses of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib in Healthy Japanese and White Adults. Clin Pharmacol Drug Dev. 2022 Jul;11(7):832-842. doi: 10.1002/cpdd.1094. Epub 2022 Apr 11.
PubMed 35411669
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05927597
- Acronym / sponsor ID
- INS1007-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Insmed IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Cohort 1 (Dose 1) | Experimental | Drug: INS1007, Drug: PlaceboJapanese 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 | Drug: INS1007, Drug: PlaceboJapanese 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 | Drug: INS1007, Drug: PlaceboJapanese 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 | Drug: INS1007Japanese 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 | Drug: INS1007Japanese 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS1007Also: AZD7986, BrensocatibOral tablets. | Drug | Part A: Cohort 1 (Dose 1), Part A: Cohort 2 (Dose 2), Part A: Cohort 3 (Dose 3), Part B: Treatment Sequence 1, Part B: Treatment Sequence 2 |
| PlaceboOral tablets. | Drug | Part A: Cohort 1 (Dose 1), Part A: Cohort 2 (Dose 2), Part A: Cohort 3 (Dose 3) |
Primary outcome
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.
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.
1 secondary outcome
Part A: Pharmacodynamic Activity Based on Concentration of Biomarkers in Blood
Time frame: Up to Day 61
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Results publication: PubMed 35411669Usansky H, Yoon E, Teper A, Zou J, Fernandez C. Safety, Tolerability, and Pharmacokinetic Evaluation of Single and Multiple Doses of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib in Healthy Japanese and White Adults. Clin Pharmacol Drug Dev. 2022 Jul;11(7):832-842. doi: 10.1002/cpdd.1094. Epub 2022 Apr 11.
- Results are available in the link to the publication.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INS1007 in people with Healthy Volunteers, run by Insmed Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.