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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis

NCT07225829

Knee Osteoarthritis Synovitis of Knee

RECRUITING PHASE2

Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients / Part II

NCT01598415

Knee Osteoarthritis

COMPLETED PHASE2

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee

NCT00689273

Osteoarthritis, Knee

COMPLETED PHASE2

A First-in-human Study to Investigate Safety and Tolerability of SAR446959 in Participants With Osteoarthritis of the Knee

NCT06704932

Osteoarthritis

COMPLETED PHASE1

Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

NCT02095548

Moderate to Severe Osteoarthritis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A total of 32 participants will be enrolled in 4 cohorts, in each cohort participants will receive either 4P-004 or placebo (6:2).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

single intraarticular administration in the knee joint

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

4P-004

single intraarticular administration in the knee joint

Intervention Type DRUG

Placebo

single intraarticular administration in the knee joint

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Liraglutide NaCl

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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 \[tests performed within the previous 12 months\]).

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 IA 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, or any inflammatory joint 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No