Safety Study of Four Doses of the Study Drug, HF1020 in Healthy Volunteers
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
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blind Placebo-controlled Study to Assess the Safety of Four Single Ascending Doses of HF1020 in Healthy Male Subjects|
- Adverse Events [ Time Frame: Up to day 15 ]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.
|Study Start Date:||July 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
|Placebo Comparator: Placebo||
Drug: HF1020 placebo
Single dose: HF1020 placebo capsule
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425450
|Medicines Evaluation Unit|
|Manchester, Lancashire, United Kingdom, M23 9QZ|