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NCT05927597 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants
A Phase 1 study, sponsored by Insmed Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT05927597: Completed Phase 1 study, sponsored by Insmed Incorporated.
NCT05927597 is a Phase 1 study that has completed, run by Insmed Incorporated. The registered enrollment target is 82 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05927597, a Phase 1 study, has completed, sponsored by Insmed Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study 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.
Primary Outcome
Determination and comparison of the safety and tolerability of INS1007 following single and multiple dose administration in Japanese and Caucasian participants.
Interventions
- DRUG Placebo
- DRUG INS1007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 1 |
What the finished NCT05927597 record still lists
NCT05927597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05927597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05927597 about?
NCT05927597 is a clinical study titled "A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants". 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 administe...
What is the current status of trial NCT05927597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2019-01-09. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT05927597?
The interventions under investigation include: Placebo (DRUG), INS1007 (DRUG).
Who is sponsoring clinical trial NCT05927597?
This trial is sponsored by Insmed Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05927597's enrollment target sits among peer trials
82 669th of 2000 higher than 1,330 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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