SPC3649 Multiple Dose Study in Healthy Volunteers

This study has been completed.

Sponsor:

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

History of Changes

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 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

Eligibility


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

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

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

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 21, 2017

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