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 with osteoarthritis of the knee

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225367

Enrollment

Registered

2020-08-27

Start date

2020-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Osteoarthritis of the knee

Interventions

investigational material(s) Generic name etc : LNA043 INN of investigational material : - Therapeutic category code : 49- Other agents affecting cellular function Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion 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 OA 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

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 OA of the knee within 4 weeks prior to screening * Malalignment >10 in the target knee (varus/valgus)

Design outcomes

Primary

Measure	Time frame
safety Adverse events, vital signs, ECG, safety laboratory tests	—

Secondary

Measure	Time frame
pharmacokinetics Serum concentrations of LNA043 and ANGPTL3 and PK parameters Pooled urine sample collection to investigate urine PK	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026