This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

SPC3649 Multiple Dose Study in Healthy Volunteers

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

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 ]

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

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


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
  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 identifier: NCT00979927

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

Responsible Party: Santaris Pharma A/S 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

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 processed this record on September 21, 2017