SPC3649 Multiple Dose Study in Healthy Volunteers
This study has been completed.
Sponsor:
Santaris Pharma A/S
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
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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:
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 (Adult) |
| 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
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
| 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 |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis C Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on September 23, 2016