Study population
Study subjects were recruited from BlueClinical Phase I’s pool of
healthy volunteers and underwent a screening procedure comprising
medical history, physical examination, vital signs, 12-lead
electrocardiogram (ECG), CPT, and clinical laboratory safety tests.
The main inclusion criteria were: healthy non-smoker or ex-smoker male
subject with age ≥18 and ≤55 years; absence of clinically relevant
diseases in medical history; resting seated SBP of 90-140 mmHg, DBP of
50-90 mmHg and pulse rate 45-100 bpm, inclusive; ability to tolerate the
3-minute cold stimulus phase of CPT; mean SBP increase of ≥7 mmHg during
the cold stimulus phase of CPT; absence of relevant abnormalities on
physical examination, 12-lead ECG, and clinical laboratory safety tests.
The main exclusion criteria were: previous exposure to zamicastat;
hypersensitivity and/or allergy reaction to the investigational
medicinal product (IMP) or any of the excipients; any medical or
surgical condition that may affect drug pharmacokinetics or subject
safety; clinically relevant history of fainting, syncope, orthostatic
hypotension, vasovagal reaction; history of alcoholism or drug abuse in
the past two years; history of arterial hypertension, diabetes mellitus
or Raynaud’s phenomenon; orthostatic hypotension; QT interval corrected
with Fridericia’s formula (QTcF) > 450 msec. Subjects who
met all the inclusion criteria and none of the exclusion criteria at the
screening visit were considered eligible for participation in the study.
Written informed consent was obtained from each prospective subject
prior to any study procedure, after the physician provided all the
information about the implications of participating in the study.
Subjects were assured that they might abandon the study at any time
without any prejudice.
SARS-CoV-2 testing was performed prior to admission to each study
period.