The study aims to: * study the safety of the drug (HF1020) in healthy male adults * study how well the study drug (HF1020) is tolerated in healthy male adults * find the maximum dose that is tolerated in healthy male adults
This is a single-centre, randomised, double-blind, placebo-controlled, ascending dose study. Male subjects will be randomised to give a total of 32 evaluable subjects. Subjects will be sequentially enrolled into 4 cohorts of ascending dose. Subjects in Cohort 1 will be randomised to receive 0.5 milligrams (mg) HF1020 or placebo (ratio 3:1). When at least 8 subjects within the cohort have completed Day 2 procedures (i.e. Day 1 + 24 hours) and all ongoing subjects have completed the final Day 15 visit, a Safety Review Committee (SRC) will meet, review all safety data prior to dose escalation to the next cohort. Subjects in Cohort 2 will be randomised to receive 2.5 mg HF1020 or placebo. Subjects in Cohort 3 will be randomised to receive 10mg HF1020 or placebo. Subjects in Cohort 4 will be randomised to receive 25mg HF1020 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Single doses at 0.5 mg capsules, 2.5 mg capsules, 10 mg capsules, and 25 mg capsules in each of cohorts 1, 2, 3 and 4 respectively.
Single dose: HF1020 placebo capsule
Medicines Evaluation Unit
Manchester, Lancashire, United Kingdom
Adverse Events
All Adverse events occuring from consent until subject completion will be reviewed at each clinic visit. Subjects will be questioned regarding any events that may have occured between clinic vists.
Time frame: Up to day 15
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