Back to resultsSPC3649 Multiple Dose Study in Healthy Volunteers
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
SPC3649
saline
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Antisense, miR-122 antagonist, safety in healthy Volunteers, Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Sites / Locations
- PRA international
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Saline
SPC3649
Arm Description
Outcomes
Primary Outcome Measures
Number of subjects experiencing adverse events
Secondary Outcome Measures
Peak Plasma Concentration (Cmax) of SPC3649
Effect on total Cholesterol
Full Information
NCT ID
NCT00979927
First Posted
September 17, 2009
Last Updated
October 4, 2011
Sponsor
Santaris Pharma A/S
1. Study Identification
Unique Protocol Identification Number
NCT00979927
Brief Title
SPC3649 Multiple Dose Study in Healthy Volunteers
Official Title
A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santaris Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Antisense, miR-122 antagonist, safety in healthy Volunteers, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Title
SPC3649
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SPC3649
Intervention Description
5 weekly doses
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
5 weekly doses
Primary Outcome Measure Information:
Title
Number of subjects experiencing adverse events
Time Frame
Up to 169 Days
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of SPC3649
Time Frame
Up to 169 Days
Title
Effect on total Cholesterol
Time Frame
Up to 169 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Hadi, MD,MSc
Organizational Affiliation
PRA Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
PRA international
City
Zuidlaren
ZIP/Postal Code
9471
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
SPC3649 Multiple Dose Study in Healthy Volunteers
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