Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL … (NCT05419856) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetics of Intraarticular 4P004 Single Dose in Patient With KL 2-4 Osteoarthritic Knee
Belgium34 participantsStarted 2022-08-09
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Participants who have the capacity to give informed consent and who are willing to comply with all study related procedures and assessments (consent via legally authorized representative will not be accepted),
* Ambulatory participants, agreeing a 24-hour hospitalization,
* Participants between 18 and 80 years of age,
* Female participant of childbearing potential (WOCBP), must use contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see section 11.4) for at least 5 days following IMP injection, and must have a negative urine pregnancy test done within 24h before randomization,
* Male participants (whose partners are of childbearing potential) must consent to use methods of contraception consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see section 11.4), for at least 90 days following IMP injection,
* Participants with knee osteoarthritis, KL 2-4 of their target knee (defined at screening as the knee with greater pain based on the participant's evaluation and the investigator's clinical judgment),
* X-rays of the target knee within 6 months (if not, to be performed before randomization),
* ECG within normal range,
* WBC (white blood cell count) \> 3500/µL,
* Hemoglobin \> 12 g/dL,
* Platelets \> 100,000/ µL,
* Creatinine clearance (CrCl) \> 60 mL/min,
* Glycemia within normal range,
* AST, ALT \< 1.5 upper l…
What they're measuring
1
Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.