drugset / Trial / NCT03355196

First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients

NCT03355196 ↗

Phase 1 Completed 42 enrolled Novartis Pharmaceuticals
NaParallel-groupDouble-blindTreatment

Summary

This study is designed to evaluate, for the first time in humans, safety and tolerability of single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of patients with moderate osteoarthritis (OA), in order to support the further clinical development. This study will also allow establishment of the systemic and local pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and regeneration in OA patients.

Timeline

Start
2017-11-20
Primary completion
2019-03-26
Completion
2019-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject LRX712 Unknown — Other

Indications

No indication recorded.