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Safety, Tolerability and Pharmacokinetics of Intra-articular (IA) Single Ascending Dose of 4P-004 in Patient With Kellgren and Lawrence Grade 2 to 4 Osteoarthritic (OA) Knee — LASARE  

Knee Osteoarthritis Clinical Trial

Official title:
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of 4P-004 Versus Placebo Injected in the Target Knee Joint of Patients With Grade 2 to 4 Osteoarthritis on the Kellgren and Lawrence Severity Index (KL 2-4)

Clinical Trial Summary

This phase I study is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending dose of IA 4P-004 at 0.3, 1.0, 2.0 and 3.0 mg in participants, - Between 18 and 80 years of age, - with target knee OA stage KL 2-4 A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05419856
Study type Interventional
Source 4P-Pharma
Contact
Status Completed
Phase Phase 1
Start date August 9, 2022
Completion date October 31, 2023
View Details
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