Overview

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)