Safety Study of SPC3649 in Healthy Men

Santaris Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: SPC3649

Study type: Interventional

Funder types: Industry

Identifiers

NCT00688012

EudraCT nummer 2008-001012-20

SPC3649-201

Details and patient eligibility

About

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

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.