SPC3649 Multiple Dose Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT00979927
First received: September 17, 2009
Last updated: October 4, 2011
Last verified: October 2011

September 17, 2009
October 4, 2011
September 2009
September 2010   (final data collection date for primary outcome measure)
Number of subjects experiencing adverse events [ Time Frame: Up to 169 Days ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00979927 on ClinicalTrials.gov Archive Site
  • Peak Plasma Concentration (Cmax) of SPC3649 [ Time Frame: Up to 169 Days ] [ Designated as safety issue: No ]
  • Effect on total Cholesterol [ Time Frame: Up to 169 Days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
SPC3649 Multiple Dose Study in Healthy Volunteers
A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Drug: SPC3649
    5 weekly doses
  • Drug: saline
    5 weekly doses
  • Placebo Comparator: Saline
    Intervention: Drug: saline
  • Active Comparator: SPC3649
    Intervention: Drug: SPC3649
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00979927
SPC3649-202, Eudract no 2009-012153-38
No
Santaris Pharma A/S
Santaris Pharma A/S
Not Provided
Principal Investigator: Salah Hadi, MD,MSc PRA International
Santaris Pharma A/S
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP