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OpenTrials
Completed

NCT Number: NCT01284582

Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP)

Phase 1 Study :Safety, Immunogenicity and Dose response of ATH03, a new vaccine against the cholesterol ester transfer protein (CETP), in healthy male subjects with high density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl.

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Key information

Conditions

HDL Behavior Drug Safety Inhibition, Psychological

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Department for Clinical Pharmacology Medical University Vienna

Vienna, State of Vienna, 1090, Austria

About this study

This open-label Phase 1 study will be conducted in three groups of 12 subjects with HDLc blood concentrations equal or below 80 mg/dl at a single study center. 36 subjects will be enrolled.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males
  • High density lipoprotein cholesterol (HDLc) blood concentrations equal or below 80 mg/dl

Exclusion criteria

  • Clinically relevant pathological findings

Treatment and study plan

ATH03

Biological

4 vaccinations

Primary outcomes

  1. Number of adverse events

    Time frame: 264 days

Secondary outcomes

  1. Immunogenicity

    Time frame: 264 days

  2. Response to the various applied doses of ATH03

    Time frame: 264 days

Sponsors and collaborators

Lead sponsor

Affiris AG

Industry

Registry information

Official study title

Safety, Immunogenicity and Dose Response of ATH03, a New Vaccine Against the Cholesterol Ester Transfer Protein (CETP), in Healthy Male Subjects With High Density Lipoprotein Cholesterol (HDLc) Blood Concentrations Equal or Below 80 mg/dl

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Oct 5, 2012

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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