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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04564053
Other study ID # CLNA043A11101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 23, 2020
Est. completion date December 10, 2020

Study information

Verified date August 2022
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LNA043
Single intra-articular injection on Day 1
Placebo
Single intra-articular injection on Day 1

Locations

Country Name City State
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Shinjuku-ku Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

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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