Healthy Volunteer Study Clinical Trial
Official title:
A Randomised, Double-blind Placebo-controlled Study to Assess the Safety of Four Single Ascending Doses of HF1020 in Healthy Male Subjects
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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