Overview

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

Status:
Not yet recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
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, 3.0 and 6.0 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). 4P-004 dose will increase with cohort 1 to 4.
Phase:
Phase 1
Details
Lead Sponsor:
4Moving Biotech