Adrecizumab Dose Escalation Safety and Tolerability Evaluation (ADESTE)
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
This is an open, standard therapy controlled clinical trial using a single intravenous
infusion of HAM8101 (Adrecizumab) in patients hospitalized for AHF. This study will serve as
a safety trial for HAM8101 (Adrecizumab) in AHF, using a dose escalating design.
Acute Heart Failure (AHF), both as deterioration of chronic stable condition or "de novo"
onset constitutes a major indication of particular interest and continues to be a major
health problem, with millions of people being affected, still associated with high mortality
and rehospitalization rates despite numerous attempts to improve the situation.
It is believed that deteriorated vascular integrity and function, which manifests in various
symptoms resulting from extravasation of fluid and solutes, is a key mechanism contributing
to development and progression of the disease.
Therefore, it is warranted to start a phase 2 safety and proof of concept study with a new
investigational product (IMP) that enhances the plasma concentration of bio-ADM in the
circulation to restore and stabilize the vascular integrity and function in patients with AHF
after initial stabilization with the current standard of care (SoC).