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
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: 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 August 01, 2014