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

• Status: Completed
• Trial end date: 2020-12-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male and female Japanese participants aged 20 to 80 years at screening

• A body mass index (BMI) 16.0 kg/m2 or more but less than 35.0 kg/m2 at screening

• Established diagnosis of primary tibio-femoral osteoarthritis of the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months prior to screening (clinical and radiological criteria).

Exclusion Criteria:

• Partial or complete joint replacement in the target knee. Planned knee surgery for either knee during the study.

• Arthroscopy of the target knee within 6 months prior to Screening or planned during the study

• Use of electrotherapy, acupuncture, and/or chiropractic treatments for osteoarthritis of the knee within 4 weeks prior to screening

• Malalignment >10° in the target knee (varus/valgus)