Safety Study of SPC3649 in Healthy Men

This study has been completed.
Sponsor:
Information provided by:
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT00688012
First received: May 7, 2008
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

A placebo-controlled, double-blind, randomized, single dose, dose escalating trial in healthy men to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPC3649.


Condition Intervention Phase
Hepatitis C
Drug: SPC3649
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double-blind, Randomized, Single Dose, Dose Escalating Trial in Healthy Men to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

Resource links provided by NLM:


Further study details as provided by Santaris Pharma A/S:

Estimated Enrollment: 64
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Volunteers
  • BMI: 19-28 kg/m2
  • No clinically significant disease/disorder
  • Screening laboratory tests without clinically significant abnormalities, must agree to use condoms during intercourse for one week after study drug infusion
  • Following receipt of verbal and written information about the study, the subject must provide signed informed consent before any study related activity is carried out.

Exclusion Criteria:

  • Heavy exercise within the past 7 days
  • Alcohol intake> 21 units weekly
  • Regular smoker
  • Received experimental drug within 30 days of study entry
  • Planned participation in any experimental study during the study period
  • HIV-Ab, HBsAg and/or HCV Ab positive
  • History of specific allergy
  • Current use of any drug or narcotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688012

Locations
Denmark
PhaseOne Trials, Hvidovre University Hospital
Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Santaris Pharma A/S
  More Information

No publications provided

Responsible Party: Joan Drejer/Regulatory Manager, Santaris Pharma
ClinicalTrials.gov Identifier: NCT00688012     History of Changes
Other Study ID Numbers: SPC3649-201, EudraCT nummer 2008-001012-20
Study First Received: May 7, 2008
Last Updated: September 17, 2009
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Santaris Pharma A/S:
antisense
microRna antagonist
anti-miR-122
Safety in healthy volunteers
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014