GL-0719

Study Details

This study involves a 2-night stay, 2 x 1-night stays, and 8 follow up visits.

Additional Details

GL-0719 – A Phase 1, Double-blind, Placebo-controlled, Single Ascending Intravenous and Subcutaneous Injection Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and an Open‑label Evaluation of Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Patients with Cold Agglutinin Disease (“the Study”).

GL-0719 is given as a set of injections under the skin. The are no injections or infusions into a vein.

Drug injections are initially planned to be given on five days in the study over the course of 28 days (once per week) but may be changed to injections twice per week. Participation would include three periods over overnight supervision in the Fortrea clinic and 8 outpatient visits to administer drug injections and monitor primarily safety, tolerability, drug levels, and efficacy signals.

GL-0719 has already been given to around 50 healthy volunteers as either an infusion into a vein or injections under the skin. GL-0719 has also been given to 3 CAD patients as injections under the skin. When given as a slow infusion into a vein or as injections under the skin the study drug was tolerated very well in both healthy volunteers and CAD patients.

You will be paid £8,250 for taking part in this study when you complete all visits. To enhance convenience of your trips to the Unit, Fortrea will order and pay for a taxi to take you from your home to the Unit and back again or, if you arrange your own transport, will pay you an additional travel payment based on the distance of your home from the Fortrea unit.