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

NCT05419856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-06-26

Study results available
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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

Interventions

DRUG

4P-004

single intraarticular administration in the knee joint

DRUG

Placebo

single intraarticular administration in the knee joint

Sponsors & Collaborators

  • 4Moving Biotech

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

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 NCT05419856 on ClinicalTrials.gov