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SPC3649 Multiple Dose Study in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00979927
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : October 5, 2011
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S

Study Description
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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 Design
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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
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Saline Drug: saline
5 weekly doses
Active Comparator: SPC3649 Drug: SPC3649
5 weekly doses


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Santaris Pharma A/S
ClinicalTrials.gov 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:
Antisense
miR-122 antagonist
safety in healthy Volunteers
Hepatitis C

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