Safety Study of SPC3649 in Healthy Men

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Santaris Pharma A/S

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.