Healthy Volunteers Clinical Trial
Official title:
A Randomized Double-blind Placebo-controlled Phase 1 Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of ADRECIZUMAB (HAM8101) in Healthy Male Subjects
This is the first clinical trial with ADRECIZUMAB. The purpose of this clinical trial to identify safety and tolerability of different doses of ADRECIZUMAB in healthy volunteers.
Adrenomedullin (ADM) is a natural occurring 52 amino acid peptide which is mainly expressed
in endothelial and smooth muscle cells. ADM plasma levels are increased in patients with
sepsis and related with severity of disease. ADM is a key regulator of vasotonus and of
endothelial integrity in sepsis.
ADRECIZUMAB is an antibody against the N-terminus of ADM which only partially inhibits the
bioactivity of ADM. Several septic animal studies have shown that administration of
ADRECIZUMAB leads to reduced catecholamine demand, improved renal function, improved fluid
balance and improved survival.
The administration of ADRECIZUMAB to rodents and non-human primates (NHP) has been tolerated
very well. Single dose and repeated administrations over 14 days to rats and NHP in the GLP
toxicology and safety study have not shown any clinical side-effects or histopathological
findings.
Based on these data the starting dose for human beings should be 0.5 mg/kg ADRECIZUMAB as
single infusion over 1 hour and should be increased up to 8 mg/kg.
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