At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
4P-004 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating 4P-004 and Placebo for Knee Osteoarthritis. Completed, enrolled 34 participants across 3 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesBelgium
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartAug 2022
Primary CompletionOct 2023
TodayJul 2026
First PostedJun 15, 2022
Enrollment StartAug 9, 2022
Primary CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.0 years ago
Interventions
4P-004drug
single intraarticular administration in the knee joint
Placebodrug
single intraarticular administration in the knee joint