Evaluation of Safety, Tolerability, and Pharmacokinetics of Intra-Articular 4P-004 in Patients with Kellgren and Lawrence Grade 2-4 Knee Osteoarthritis
- Trial ID
- 2022-500271-31-00
- Protocol
- 4MB-LAS-P
- Sponsor
- 4moving Biotech
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **safety**, **tolerability**, and **pharmacokinetics** of a single ascending dose of 4P-004 administered intra-articularly in patients with knee **osteoarthritis** classified as Kellgren and Lawrence grade 2 to 4. This assessment is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with 4P-004, which could inform future treatment strategies for managing knee osteoarthritis, a condition characterized by joint pain and functional impairment.
Participants
The clinical trial focuses on individuals diagnosed with **knee osteoarthritis**. The study population includes both male and female participants, with an age range that encompasses adults and older adults. The trial involves a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. Participants were selected based on criteria that are not disclosed in the available data. Lifestyle considerations such as diet, physical activity, or habits are not specified. The trial aims to gather insights from a diverse group, ensuring representation across different age groups and genders, while focusing on a condition prevalent in the specified demographic.
Plans and Procedures
The clinical trial is designed to evaluate the **safety**, tolerability, and pharmacokinetics of a single ascending dose of 4P-004 administered intra-articularly in patients with knee **osteoarthritis** classified as Kellgren and Lawrence grade 2 to 4. This study is a Phase 3 trial, employing a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on June 30, 2022, and conclude by September 29, 2023, with the overall duration of the trial spanning approximately 15 months.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized and receive the investigational product. Subsequent follow-up visits will be scheduled to monitor the participants' response to the treatment, assess any adverse events, and collect pharmacokinetic data. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the long-term effects of the treatment.
The expected length of participant involvement in the study is contingent upon the trial's schedule and the individual's response to the treatment. Participants may be subject to early termination from the study if they experience significant adverse events, fail to comply with the study protocol, or withdraw consent. The trial's design and procedures are structured to ensure the collection of comprehensive data while maintaining participant safety and adherence to ethical standards.
Treatment
The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.
Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment regimen comprehensively.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 3 study. The trial's estimated recruitment start date was June 30, 2022, with an estimated end date of September 29, 2023. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial does not provide information on the tools or instruments involved in efficacy assessments. The focus remains on objectively determining the efficacy of the intervention under investigation within the specified trial phase.
Inclusion and Exclusion Criteria
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-ray of the target knee within 6 months (if not, to be performed before randomization)
- ECG within normal range
- WBC (white blood cell count) > 3.5/µL
- Hemoglobin > 12 g/dL
- Platelets > 100,000/ µL
- Creatinine clearance (CrCl) > 60 mL/min
- Glycemia within normal range
- AST, ALT < 1.5 upper limit of normal (ULN)
- Amylasemia < 1ULN
- Negative tests for COVID-19 (if required by the standard practice on site), HIV, HbsAg and hepatitis C Ab (Determination of HIV and hepatitis status can be based on participant reported medical history, available medical records, and the most recently available laboratory results for the participant)
Exclusion Criteria
- Breastfeeding women
- Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
- Any treatment with glucosamine or chondroitin sulfate in the previous 3 months
- Any glucagon-like peptide 1 analogue hormones
- Anticoagulant treatment (current or within the last 10 days)
- Treatment of the target knee with any intra-articular injection (steroids, hyaluronic acid derivatives, PRP ….) within 3 months
- Knee surgery (of the target knee) performed within the previous 12 months or planned within the next 6 months
- Any partial knee replacement of the target knee
- Any known active infections or increased predisposition for the development of infections
- Clinical signs and symptoms of active joint crystal disease
- Diabetes type I or II
- Congestive Heart Failure stage III or IV of NYHA classification
- Inflammatory bowel disease
- Any other chronic condition that has not been well controlled for a minimum of 3 months
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer) within the last 5 years
- Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation, (for example, any abnormal reaction to previous IA injection)
- Hypersensitivity to the active substance liraglutide or to any of the excipients: Disodium phosphate dihydrate, Propylene glycol, Phenol
- Participation in an interventional clinical research trial within 12 weeks prior
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Not Recruiting | 30 Jun 2022 | 32 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
MINI-PLASCO NACL B. BRAUN 0,9 %, solution injectable | Placebo | SOLUTION INJECTABLE | INTRAARTICULAR USE | 2 | 1 | PRD5414432 |
Victoza 6 mg/ml solution for injection in pre-filled pen | Test | SOLUTION FOR INJECTION IN PRE-FILLED PEN | INTRAARTICULAR USE | 6 | 1 | PRD344598 |
MINI-PLASCO NACL B. BRAUN 0,9 %, solution injectable | Placebo | SOLUTION INJECTABLE | INTRAARTICULAR USE | 2 | 1 | PRD5415212 |