SPC3649 Multiple Dose Study in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00979927
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : October 5, 2011
Information provided by (Responsible Party):
Santaris Pharma A/S

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: SPC3649 Drug: saline Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Placebo Comparator: Saline Drug: saline
5 weekly doses

Active Comparator: SPC3649 Drug: SPC3649
5 weekly doses

Primary Outcome Measures :
  1. Number of subjects experiencing adverse events [ Time Frame: Up to 169 Days ]

Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of SPC3649 [ Time Frame: Up to 169 Days ]
  2. Effect on total Cholesterol [ Time Frame: Up to 169 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00979927

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

Responsible Party: Santaris Pharma A/S Identifier: NCT00979927     History of Changes
Other Study ID Numbers: SPC3649-202
Eudract no 2009-012153-38
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: October 5, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections