Back to resultsSafety Study of SPC3649 in Healthy Men
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
SPC3649
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring antisense, microRna antagonist, anti-miR-122, Safety in healthy volunteers, Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Healthy Volunteers
- BMI: 19-28 kg/m2
- No clinically significant disease/disorder
- Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
- Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.
Exclusion Criteria:
- Heavy exercise within the past 7 days
- Alcohol intake> 21 units weekly
- Regular smoker
- Received experimental drug within 30 days of study entry
- Planned participation in any experimental study during the study period
- HIV-Ab, HBsAg and/or HCV Ab positive
- History of specific allergy
- Current use of any drug or narcotics.
Sites / Locations
- PhaseOne Trials, Hvidovre University Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688012
Brief Title
Safety Study of SPC3649 in Healthy Men
Official Title
A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Santaris Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
antisense, microRna antagonist, anti-miR-122, Safety in healthy volunteers, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SPC3649
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers
BMI: 19-28 kg/m2
No clinically significant disease/disorder
Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.
Exclusion Criteria:
Heavy exercise within the past 7 days
Alcohol intake> 21 units weekly
Regular smoker
Received experimental drug within 30 days of study entry
Planned participation in any experimental study during the study period
HIV-Ab, HBsAg and/or HCV Ab positive
History of specific allergy
Current use of any drug or narcotics.
Facility Information:
Facility Name
PhaseOne Trials, Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
12. IPD Sharing Statement
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Safety Study of SPC3649 in Healthy Men
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