PPS trials, page-6

Take two. Frustrating trying to format articles taken from other websites.

Interesting find on the Australian Clinical Trials website. I was not aware of this trial PAR is doing on Healthy Adult Participants.

A Phase 1, Open-label Study to Determine the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Doses of Pentosan Polysulfate Sodium (PPS) in Healthy Adult Participants

Trial summaryParadigm Biopharmaceuticals Ltd (Paradigm) is focusing on Pentosan Polysulfate Sodium (PPS) for the treatment of conditions that are associated with inflammation and progress chronically with tissue degeneration, including the treatment of Osteoarthritis Knee pain. Previous studies demonstrate that PPS is tolerated at the proposed dose (2 mg/kg) and duration (once or twice weekly for 6 weeks). While most of the clinical data obtained were acquired using a twice weekly regimen, a once weekly SC injection program, if effective and safe, would be ideal for feasibility.This study is will assess safety, tolerability, and pharmacokinetic responses of multiple sub-cutaneous doses of PPS in a healthy western population to support the development program.The clinical and nonclinical evidence demonstrate that PPS is tolerated at the proposed dose (2 mg/kg) and duration (once or twice weekly for 6 weeks). In two studies evaluating dose limiting toxicity, maximum tolerated doses were determined to be 3 mg/kg/day continuous infusion (Pluda et al., 1993) and 22.5 mg/m2 SC injection every 6 hours (Swain et al., 1995). Assuming an average male of 60 kg and 1.9 m, these doses are roughly equivalent to 180 mg/day and 171 mg/day, respectively. These levels are greater than the Sponsor’s current proposed dosing regimen of 2 mg/kg (approximately 120 mg) SC once or twice per week.The PK sampling design in this study will allow comparison with an earlier PK study which evaluated 50 mg to 300 mg PPS administered by SC injection once weekly for 4 weeks. While most of the clinical data obtained were acquired using a twice weekly regimen, a once weekly SC injection program, if effective and safe, would be ideal for feasibility. Therefore, PK data obtained from once and twice weekly dosing regimens will support the development program
https://www.australianclinicaltrials.gov.au/anzctr_feed/result?searchText=pentosan&purposeOfStudy=&recruitmentStatus=Recruiting&phase=ðicsApproval=Yes&gender=&healthyVolunteers=&recruitmentSites=&healthConditions=&ageGroup=&recruitmentCountries=Australia&studyType=&conditionCategory=All&conditionCode=&paging=20&page=0