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

Phase 1

Completed

• Conditions: HDL; Drug Safety
• Interventions: Biological: ATH03

• Registration Number: NCT01284582
• Lead Sponsor: Affiris AG

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-05
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-04
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

• Clinically relevant pathological findings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATH03 Group A	ATH03	ATH03, 10 µg, 0.2% Alum
ATH03 Group B	ATH03	ATH03, 30 µg, 0.2% Alum
ATH03 Group C	ATH03	ATH03, 100 µg, 0.2% Alum

Primary Outcome Measures

Name	Time	Method
Number of adverse events	264 days

Secondary Outcome Measures

Name	Time	Method
Response to the various applied doses of ATH03	264 days
Immunogenicity	264 days

Trial Locations

Locations (1)

Department for Clinical Pharmacology Medical University Vienna; 🇦🇹 Vienna, Austria