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

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.

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.

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)