NCT01284582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

January 25, 2011

Last Update Submit

October 4, 2012

Conditions

HDLDrug Safety

Keywords

CETPVaccineCholesterolInhibition

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    264 days

Secondary Outcomes (2)

  • Immunogenicity

    264 days

  • Response to the various applied doses of ATH03

    264 days

Study Arms (3)

ATH03 Group A

EXPERIMENTAL

ATH03, 10 µg, 0.2% Alum

Biological: ATH03

ATH03 Group B

EXPERIMENTAL

ATH03, 30 µg, 0.2% Alum

Biological: ATH03

ATH03 Group C

EXPERIMENTAL

ATH03, 100 µg, 0.2% Alum

Biological: ATH03

Interventions

ATH03BIOLOGICAL

4 vaccinations

ATH03 Group AATH03 Group BATH03 Group C

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Clinically relevant pathological findings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Clinical Pharmacology Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Inhibition, Psychological

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Achim Schneeberger, MD

    Affiris AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

AU(1)