protocolSection identificationModule nctId: NCT06263270, orgStudyIdInfo id: 12-2023-01, briefTitle: Evaluation of CYT-108, a Recombinant Protease Inhibitor, for Treatment of Mild to Moderate Primary Osteoarthritis of the Knee, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Cytonics Corporation, class: INDUSTRY, collaborators name: Southern Star Research Pty Ltd., descriptionModule briefSummary: The goal of this Phase 1 study is to investigate the safety of CYT-108, our experimental recombinant protease inhibitor drug candidate for osteoarthritis, in a population of patients suffering from osteoarthritis of the knee. The main questions this study aims to answer are:1. are two doses of CYT-108, delivered 12 weeks apart, safe when injected directly into the joint?2. does administration of CYT-108 result in a reduction in pain, stiffness, and improvement in daily physical function?Participants will either receive a placebo (Phosphate Buffer Saline, PBS) or CYT-108, and will be asked to report their pain/stiffness at weeks 1, 4, 8, 12, 16, and 26 (in a physician's office) after the initial injection, using a questionnaire to be provided by the physician. In addition to reporting the magnitude of pain, participants will also be asked about the onset of pain reduction. Researchers will compare the pain/stiffness scores between the CYT-108-treated to placebo-treated groups along the 26 week duration of the study. Participants will also receive blood draws along the course of the study, and researchers will analyze this blood for the presence of cartilage degradation product in attempt to identify "disease modification" (i.e., a reduction in cartilage degradation) in response to CYT-108 treatment., conditionsModule conditions: Osteoarthritis, Knee, conditions: Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The Phase 1a trial will be a multicenter, double-blind, randomized, placebo-controlled clinical study to evaluate the safety of two doses of CYT-108 (given at Day 1 and Day 85) in participants with mild to moderate primary OA of the knee, followed out to 26 weeks. A Screening Visit will be performed between twenty-eight days to two days before the first dose, (i.e., Days -28 to -2), and if eligible, participants will attend baseline evaluation on Day 1 to confirm eligibility before randomisation to treatment. The first and second doses will be administered on Day 1 and Day 85 (12 weeks post-first dose, with six follow-up visits on Days 8, 29, 57, 85, 113, and 183; Weeks 1, 4, 8, 12, 16, and 26 weeks post-first dose respectively)., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: This study is double-blind, placebo-controlled. Neither the investigator, care providers, patients, nor study sponsor have knowledge of the interventions assigned to each participant., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: CYT-108, a recombinant protease inhibitor, interventions name: Phosphate Buffered Saline (PBS), outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Heart Rate, primaryOutcomes measure: Respiratory Rate, primaryOutcomes measure: Body Temperature, primaryOutcomes measure: Titer of Human Anti-Drug Antibody, secondaryOutcomes measure: Change in WOMAC Scores (Pain, Stiffness, and Difficulty Performing Daily Activities), secondaryOutcomes measure: Time of Onset, otherOutcomes measure: Concentration of Cartilage Degradation Fragments in Blood Plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emeritus Research, city: Camberwell, state: Victoria, zip: 3124, country: Australia, contacts name: Stuart Game, MD, role: CONTACT, phone: +61 3 9509 6166, email: stuartgame@emeritusresearch.com, geoPoint lat: -37.84205, lon: 145.0694, hasResults: False