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. |
ClinicalTrials.gov Identifier: NCT00979927 |
Recruitment Status
:
Completed
First Posted
: September 18, 2009
Last Update Posted
: October 5, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
|
- Number of subjects experiencing adverse events [ Time Frame: Up to 169 Days ]
- Peak Plasma Concentration (Cmax) of SPC3649 [ Time Frame: Up to 169 Days ]
- Effect on total Cholesterol [ Time Frame: Up to 169 Days ]

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, Learn About Clinical Studies.
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

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
Netherlands | |
PRA international | |
Zuidlaren, Netherlands, 9471 |
Principal Investigator: | Salah Hadi, MD,MSc | PRA Health Sciences |
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 |