To determine the safety and tolerability of single escalating doses of Sulforadex® in healthy male volunteers.
This study will be conducted in a randomised, double-blind, placebo-controlled design with single ascending doses of Sulforadex® administered to healthy male subjects between 18 to 45 years of age. Each healthy subject will receive verbal and written information followed by signing of the Informed Consent Form (ICF). Subjects will be screened within 21 days prior to admission. At this visit a medical examination will be performed to assess eligibility of the healthy subject. Screening will be conducted over 1 day or may be divided into more than 1 day. The first cohort of the study will commence with one sentinel group. The subsequent groups may be dosed together without sentinel dosing. The study is expected to have 5 cohorts with a total of 29 healthy male subjects:
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
29
Active compound
Placebo control
Richmond Pharmacology
London, United Kingdom
Safety
Safety assessments will include standard laboratory safety tests (haematology, biochemistry, coagulation and urinalysis), vital signs, physical examinations, 12-lead ECG, telemetry and AE monitoring.
Time frame: 2 days
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