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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
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatitis C
 Drug: SPC3649
Drug: saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Santaris Pharma A/S:

Primary Outcome Measures:
  • Number of subjects experiencing adverse events [ Time Frame: Up to 169 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]
Estimated Enrollment: 30
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline Drug: saline
5 weekly doses
Active Comparator: SPC3649 Drug: SPC3649
5 weekly doses

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979927

Locations
Netherlands
PRA international
Zuidlaren, Netherlands, 9471
Sponsors and Collaborators
Santaris Pharma A/S
Investigators
Principal Investigator: Salah Hadi, MD,MSc PRA Health Sciences
  More Information

No publications provided

Responsible Party: Santaris Pharma A/S
ClinicalTrials.gov Identifier: NCT00979927     History of Changes
Other Study ID Numbers: SPC3649-202, Eudract no 2009-012153-38
Study First Received: September 17, 2009
Last Updated: October 4, 2011
Health Authority: The Netherlands: Ministry of Health, Welfare and Sport (VWS)

Keywords provided by Santaris Pharma A/S:
Antisense
miR-122 antagonist
safety in healthy Volunteers
Hepatitis C

ClinicalTrials.gov processed this record on February 27, 2015