Clinical Trials/NCT05419856

NCT05419856

Completed

Phase 1

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

4Moving Biotech3 sites in 1 country34 target enrollmentAugust 9, 2022

ConditionsKnee Osteoarthritis

Interventions4P-004 Placebo

Drugs4P-004 Placebo

Overview

Phase: Phase 1
Intervention: 4P-004
Conditions: Knee Osteoarthritis
Sponsor: 4Moving Biotech
Enrollment: 34
Locations: 3
Primary Endpoint: Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

August 9, 2022

End Date

October 31, 2023

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

4Moving Biotech

Responsible Party

Sponsor

Eligibility 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-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,

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,

Arms & Interventions

4P-004 w mg

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

Intervention: 4P-004

4P-004 x mg

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

Intervention: 4P-004

4P-004 y mg

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

Intervention: 4P-004

4P-004 z mg

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

Intervention: 4P-004

Placebo

Placebo is administered once intraarticularly in the target knee joint

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and Tolerability of Single IA Administration of 4P-004 at Escalating Doses in Participants With Knee OA.

Time Frame: Day 1-Day 28

Number of participants with Adverse Events, serious AEs (SAEs), with abnormal Vital signs, abnormal ECG reading and abnormal Laboratory test results

Secondary Outcomes

To Characterize the Plasma Concentration of Liraglutide When Administered as Single IA Doses at Escalating Dose Levels in Participants With Knee OA(Day 1 to Day 2)