NCT04564053

Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants

A Randomized, Participant and Investigator Blinded, Placebo Controlled, Single Ascending Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Participants Wit Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to determine the safety, tolerability and pharmacokinetics after single ascending dose of LNA043 in Japanese participants with osteoarthritis of the knee.

Detailed description

This was a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study to investigate the safety, tolerability and PK of LNA043 in Japanese participants with osteoarthritis of the knee. This study consisted of 2 cohorts with a total of 12 participants.

Conditions

• Osteoarthritis
• Knee

Interventions

Type	Name	Description
DRUG	LNA043	Single intra-articular injection on Day 1
DRUG	Placebo	Single intra-articular injection on Day 1

Timeline

• Start date: 2020-09-23
• Primary completion: 2020-12-10
• Completion: 2020-12-10
• First posted: 2020-09-25
• Last updated: 2022-08-10

Locations

2 sites across 1 country: Japan