First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement
Completed · Phase 1 · Has a placebo group
Conditions studied: Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery
In brief
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.
Key facts
- Study ID
- NCT02491281
- Run by
- Novartis Pharmaceuticals
- People needed
- 28
- Starts
- 2015-11-16
- Expected to finish
- 2018-03-06
- Last updated by the study team
- 2020-12-11
Who can join
Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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