Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-27 @ 1:31 AM
Study NCT ID:
NCT01425450
Status:
COMPLETED
Last Update Posted:
2011-10-31
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Four Doses of the Study Drug, HF1020 in Healthy Volunteers
Sponsor:
Trident Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
A Randomised, Double-blind Placebo-controlled Study to Assess the Safety of Four Single Ascending Doses of HF1020 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-023005-34 | EUDRACT_NUMBER | None | View |