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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04564053

Enrollment

Registered

2020-09-25

Start date

2020-09-23

Completion date

2020-12-10

Last updated

2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee, Osteoarthritis

Keywords

osteoarthritis, knee, cartilage

Brief 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.

Detailed 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.

Interventions

DRUGLNA043

Single intra-articular injection on Day 1

DRUGPlacebo

Single intra-articular injection on Day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

This is a non-confirmatory, randomized, participant- and investigator-blinded, placebo-controlled, single ascending dose study.

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events	Up to Day 22	To assess the safety and tolerability of single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

Secondary

Measure	Time frame	Description
Area under the serum concentration-time curve of LNA043 from zero to the last measurable concentration	0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose	To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Observed maximum serum concentration of LNA043	0 (pre-dose), 0.25, 2, 4, 8, 12, 24, 36, 48, 72, 168 hours post-dose	To assess systemic PK of LNA043 following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee
Number of participants with anti-LNA043 antibodies in serum	Day 1 (pre-dose), 4, 8, 15, 22	To assess systemic immunogenicity of LNA043 (anti-LNA043 antibodies) following single intra-articular injection of LNA043 in Japanese participants with osteoarthritis of the knee

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026