NCT01425450

Safety Study of Four Doses of the Study Drug, HF1020 in Healthy Volunteers

A Randomised, Double-blind Placebo-controlled Study to Assess the Safety of Four Single Ascending Doses of HF1020 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Trident Pharmaceuticals Inc · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	HF1020	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.
DRUG	HF1020 placebo	Single dose: HF1020 placebo capsule

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-08-30
• Last updated: 2011-10-31

Locations

1 site across 1 country: United Kingdom