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NCT04139122 · ClinicalTrials.gov registry record · Phase 1
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
A Phase 1 study of Dry Eye Disease and Dry Eye Syndrome, sponsored by Senju Pharmaceutical Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
- 1
- Study location
NCT04139122 is a Phase 1 study of Dry Eye Disease and Dry Eye Syndrome that has completed, run by Senju Pharmaceutical Co.. The registered enrollment target is 89 participants, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04139122, a Phase 1 study of Dry Eye Disease and Dry Eye Syndrome, has completed, sponsored by Senju Pharmaceutical Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SJP-0132
Study Locations (1)
California
- Senju Investigational Site - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2019-10-05 |
| Est. Completion | 2020-03-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04139122
The ClinicalTrials.gov registry entry for NCT04139122 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (65% lower). The listed sponsor is Senju Pharmaceutical Co., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04139122 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04139122 about?
NCT04139122 is a clinical study titled "Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease". This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease
What is the current status of trial NCT04139122?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2019-10-05. Estimated completion is 2020-03-03.
What conditions does trial NCT04139122 study?
This clinical trial studies the following conditions: Dry Eye Disease, Dry Eye Syndrome.
What interventions are being tested in trial NCT04139122?
The interventions under investigation include: Placebo (DRUG), SJP-0132 (DRUG).
Who is sponsoring clinical trial NCT04139122?
This trial is sponsored by Senju Pharmaceutical Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04139122 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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