The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied. Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels: * Cohort 1: 0.075 mcg/kg * Cohort 2: 0.15 mcg/kg * Cohort 3: 0.30 mcg/kg
Canberra Hospital
Garran, Australian Capital Territory, Australia
St. George Hospital
Sydney, New South Wales, Australia
Royal Brisbane
Brisbane, Queensland, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Freemantle Hospital
Fremantle, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Middlemore Hospital
Otahuhu, Auckland, New Zealand
Evaluate the overall safety of PRTX-100 during the 3 month study duration
Time frame: 3 months
Characterize the pharmacokinetics of multiple doses of PRTX-100
Time frame: over the first 35 days
Explore immunogenicity of multiple doses of PRTX-10
Time frame: 3 months
Evaluate treatment effect on platelet count
Time frame: 3 months
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