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

4Moving Biotech

Status and phase: Completed; Phase 1

Conditions: Knee Osteoarthritis

Treatments: Drug: Placebo; Drug: 4P-004

Study type: Interventional

Funder types: Industry

Identifiers

NCT05419856

4MB-LAS-P

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

34 participants in 5 patient groups, including a placebo group

4P-004 w mg

Experimental group

Description:

4P-004 is administered once intraarticularly in the target knee joint Dose = w mg

Treatment:

Drug: 4P-004

4P-004 x mg

Experimental group

Description:

4P-004 is administered once intraarticularly in the target knee joint Dose = x mg

Treatment:

Drug: 4P-004

4P-004 y mg

Experimental group

Description:

4P-004 is administered once intraarticularly in the target knee joint Dose = y mg

Treatment:

Drug: 4P-004

4P-004 z mg

Experimental group

Description:

4P-004 is administered once intraarticularly in the target knee joint Dose = z mg

Treatment:

Drug: 4P-004

Placebo

Placebo Comparator group

Description:

Placebo is administered once intraarticularly in the target knee joint

Treatment:

Drug: Placebo