Stage, Prostate Cancer Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Sulforadex® in Healthy Male Subjects
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:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment