Safety Study of SPC3649 in Healthy Men

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PhaseOne Trials, Hvidovre University Hospital

Hvidovre, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPC3649

Drug

Sponsors and collaborators

Lead sponsor

Santaris Pharma A/S

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jun 2, 2008
Registry last updated: Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed