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NCT02491281 · ClinicalTrials.gov registry record · Phase 1
First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
A Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT02491281 is a Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02491281, a Phase 1 study of Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LNA043
Study Locations (1)
Arizona
- Novartis Investigative Site - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2018-03-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02491281
The ClinicalTrials.gov registry entry for NCT02491281 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02491281 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT02491281 about?
NCT02491281 is a clinical study titled "First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement". This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage,...
What is the current status of trial NCT02491281?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-11-16. Estimated completion is 2018-03-06.
What conditions does trial NCT02491281 study?
This clinical trial studies the following conditions: Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery.
What interventions are being tested in trial NCT02491281?
The interventions under investigation include: Placebo (DRUG), LNA043 (DRUG).
Who is sponsoring clinical trial NCT02491281?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02491281 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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