Safety, Immunogenicity and Dose Response of ATH03, a New... | NCT01284582

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

NCT01284582

Sponsor

Affiris AG

Status

Completed

Last Update Posted

Oct 5, 2012Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

HDL
Drug Safety

Interventions

ATH03

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jan 25, 2011

First Submission Date that Met QC Criteria

Jan 26, 2011

First Posted Date

Jan 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2012

Last Update Posted Date

Oct 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ATH03	Biological	4 vaccinations	ATH03 Group A ATH03 Group B ATH03 Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events		264 days

Secondary Outcomes

Measure	Description	Time Frame
Immunogenicity		264 days
Response to the various applied doses of ATH03		264 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Clinically relevant pathological findings

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Achim Schneeberger, MD	Affiris AG	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Clinical Pharmacology Medical University Vienna		Vienna	State of Vienna	1090	Austria