Osteoarthritis Clinical Trial
Official title:
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
Verified date | August 2022 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 10, 2020 |
Est. primary completion date | December 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Japan | Novartis Investigative Site | Osaka | |
Japan | Novartis Investigative Site | Shinjuku-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events | To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee | Up to Day 22 | |
Secondary | Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration | To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee | 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose | |
Secondary | Observed maximum serum concentration of LNA043 | To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee | 0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose | |
Secondary | Number of participants with anti-LNA043 antibodies in serum | To assess systemic immunogenicity of LNA043 (anti-LNA043 antibodies) following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee | Day 1 (pre-dose), 4, 8, 15, 22 |
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