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

Drug Safety Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284582
• Other study ID #: AFF007
• Status: Completed
• Phase: Phase 1
• First received: January 25, 2011
• Last updated: October 4, 2012
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Affiris AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety
• HDL

Intervention

Biological:
• ATH03
4 vaccinations

Locations

Country	Name	City	State
Austria	Department for Clinical Pharmacology Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		264 days	Yes
Secondary	Immunogenicity		264 days	No
Secondary	Response to the various applied doses of ATH03		264 days	No