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

NCT05419856 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and tolerability of a single injection of the experimental drug 4P-004 in people with moderate to severe knee osteoarthritis.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 34 people

Who can join Ages 18–80 · all sexes

Timeline Started 2022-08 · est. completion 2023-10

Where 3 sites · Belgium

What this study is testing ClinicalTrials.gov NCT05419856 ↗

Description as written by the study sponsor.

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).

Treatments tested

4P-004 also known as Liraglutide Drug

single intraarticular administration in the knee joint
Placebo also known as NaCl Drug

single intraarticular administration in the knee joint

Main thing measured	Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
Sponsor	4Moving Biotech
Conditions studied	Knee Osteoarthritis
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05419856 ↗