SPC3649 Multiple Dose Study in Healthy Volunteers

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979927
• Other study ID #: SPC3649-202
• Secondary ID: Eudract no 2009-
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: October 4, 2011
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2011
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Ministry of Health, Welfare and Sport (VWS)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers: Males and postmenopausal females aged = 18 to 60 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• SPC3649
5 weekly doses
• saline
5 weekly doses

Locations

Country	Name	City	State
Netherlands	PRA international	Zuidlaren

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects experiencing adverse events		Up to 169 Days	Yes
Secondary	Peak Plasma Concentration (Cmax) of SPC3649		Up to 169 Days	No
Secondary	Effect on total Cholesterol		Up to 169 Days	No