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

Affiris

Status and phase: Completed; Phase 1

Conditions: HDL; Drug Safety

Treatments: Biological: ATH03

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284582

AFF007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Clinically relevant pathological findings

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

ATH03 Group A

Experimental group

Description:

ATH03, 10 µg, 0.2% Alum

Treatment:

Biological: ATH03

ATH03 Group B

Experimental group

Description:

ATH03, 30 µg, 0.2% Alum

Treatment:

Biological: ATH03

ATH03 Group C

Experimental group

Description:

ATH03, 100 µg, 0.2% Alum

Treatment:

Biological: ATH03