The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
This is a Phase 1b, open-label, multiple subcutaneous (SC) injection dose study in participants with ITP. The specific aims of this study are to determine: * The safety of the study drug when given to participants with ITP * The effect of the study drug on safety blood tests and blood platelet counts * How the study drug affects certain responses in the body such as severity of bleeding, levels of fatigue and health-related quality of life * How much of the study drug gets into the bloodstream * The body's immune response to the study drug This information, together with pharmacokinetic (PK) data, will help to establish doses and dosing regimens suitable for use in future studies. The effects of GL-2045 on multiple biomarkers will also be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Administrative route: SC injection
Fortrea Clinical Research Unit Ltd
Leeds, United Kingdom
RECRUITINGIncidence, severity and type of adverse events and laboratory abnormalities
Time frame: Screening (Days -28 to -2) to Follow-up (Day 55)
Multiple measurements of change from baseline in platelet count
Time frame: Day -1 to Follow-up (Day 55)
Change from Baseline in Tumor Necrosis Factor-Alpha (TNF-α) Levels
Time frame: Day 1 to Follow-up (Day 55)
Change from Baseline in Classical Complement Pathway (CCP) Inhibition
Time frame: Day 1 to Follow-up (Day 55)
Changes in bleeding scale
Time frame: Day -1 to Follow-up (Day 55)
Changes from baseline in Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Questionnaire
Time frame: Day -1 to Follow-up (Day 55)
Changes from baseline in FACIT-Thrombocytopenia 6 Questionnaire
Time frame: Day -1 to Follow-up (Day 55)
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUCO-tlast)
Time frame: Day 1 to Follow-up (Day 55)
Maximum observed concentration (Cmax)
Time frame: Day 1 to Follow-up (Day 55)
Time of the maximum observed concentration (tmax)
Time frame: Day 1 to Follow-up (Day 55)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Incidence of immune response to drug
Time frame: Day 1 to Day 48