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Completed

NCT Number: NCT00979927

SPC3649 Multiple Dose Study in Healthy Volunteers

The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.

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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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA international

Zuidlaren, 9471, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years

Treatment and study plan

SPC3649

Drug

5 weekly doses

Saline

Drug

5 weekly doses

Primary outcomes

  1. Number of subjects experiencing adverse events

    Time frame: Up to 169 Days

Secondary outcomes

  1. Peak Plasma Concentration (Cmax) of SPC3649

    Time frame: Up to 169 Days

  2. Effect on total Cholesterol

    Time frame: Up to 169 Days

Sponsors and collaborators

Lead sponsor

Santaris Pharma A/S

Industry

Registry information

Official study title

A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 18, 2009
Registry last updated
Oct 5, 2011

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.

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