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.