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First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement

NCT02491281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-12-11

No results posted yet for this study

Summary

This study is designed to evaluate the safety and tolerability of ascending single doses of LNA043 given intra-articularly into the human knee joint prior to its removal at total knee replacement surgery. In addition, this will help to establish the presence of LNA043 within the articular cartilage, assess pharmacokinetics and immunogenicity, and will allow exploration of biomarkers of hyaline cartilage repair.

Conditions

  • Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery

Interventions

DRUG

LNA043

ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

DRUG

Placebo

ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-16
Primary Completion
2018-02-07
Completion
2018-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491281 on ClinicalTrials.gov