NCT02491281

First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement

A Randomized, Placebo Controlled, Double-blind First-in-human Single Ascending Dose Study of LNA043 in Primary Osteoarthritis Patients Scheduled for Total Knee Replacement

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Interventions

Type	Name	Description
DRUG	LNA043	ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery
DRUG	Placebo	ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

Timeline

• Start date: 2015-11-16
• Primary completion: 2018-02-07
• Completion: 2018-03-06
• First posted: 2015-07-08
• Last updated: 2020-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study