NCT05419856

Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of 4P004 Versus Placebo Injected in the Target Knee of Patients With Grade 2 to 4 Osteoarthritis on the Kellgren and Lawrence Severity Index

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: 4Moving Biotech · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	4P-004	single intraarticular administration in the knee joint
DRUG	Placebo	single intraarticular administration in the knee joint

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2022-06-15
• Last updated: 2025-06-26
• Results posted: 2025-05-15

Locations

3 sites across 1 country: Belgium