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Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

Primary Purpose

Staphylococcal Sepsis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

BSYX-A110

About this trial

This is an interventional prevention trial for Staphylococcal Sepsis focused on measuring A110, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects must be 18 years of age or older.
Subjects must in good general health, without significant medical history, physical examination findings or clinical laboratory abnormalities.
Negative screening pre-treatment pregnancy test for female subjects.
Subjects of childbearing potential must agree to use an acceptable method of contraception throughout the course of the study.
All aspects of the protocol explained and written informed consent obtained.

Exclusion Criteria:

Known or suspected immunodeficiency (e.g. HIV infection, significant risk factors for HIV, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression.
Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
History of leukemia, lymphoma or other malignancy.
Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
Receipt of any vaccine within 30 days.
History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study.
Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
Participation in another investigational drug or vaccine trial within 30 days.

Sites / Locations

Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo

BSYX-A110, Dosed intravenously, 3mg/kg

BSYX-A110, Dosed intravenously, 10mg/kg

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability.

Secondary Outcome Measures

To evaluate the serum levels (pharmacokinetics) of anti-LTA antibodies (ELISA; the functional opsonic activity against S. epidermidis; and correlate the levels of anti-LTA antibodies achieved with opsonic activity against S. epidermidis

Full Information

NCT ID

NCT00636285

First Posted

February 27, 2008

Last Updated

October 8, 2008

Sponsor

Biosynexus Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT00636285

Brief Title

Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

Official Title

Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetics Study in Adults of BSYX-A110, a Human Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

September 2001 (Actual)

Study Completion Date

November 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Biosynexus Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this Phase 1 study is to evaluate the safety and pharmacokinetics of BSYX-A110 in a small number of healthy adult volunteers. Following the demonstration of safety in adults, this anti-Staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized low birth weight neonates.

Detailed Description

This study will evaluate the safety of three doses of BSYX-A110 in adults before initiating studies in the target population of low birth weight infants. This will be an open label, dose-ranging study of BSYX-A110 in 12 adults. The dose levels to be evaluated are 3, 10 and 20 mg/kg. Each dose level will enroll 4 adult volunteers who will receive one dose of BSYX-A110 intravenously. The primary endpoint of this study is safety and tolerability. The secondary endpoints include the pharmacokinetics of the rise in anti-LTA antibody and opsonic activity against S. epidermidis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staphylococcal Sepsis

Keywords

A110, Safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Experimental

Arm Description

BSYX-A110, Dosed intravenously, 3mg/kg

Arm Title

Arm Type

Experimental

Arm Description

BSYX-A110, Dosed intravenously, 10mg/kg

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Pagibaximab, BSYX-A110

Intervention Description

Placebo

Intervention Type

Drug

Intervention Name(s)

BSYX-A110

Other Intervention Name(s)

Pagibaximab

Intervention Description

BSYX-A110, Dosed intravenously, 3 mg/kg

Intervention Type

Drug

Intervention Name(s)

BSYX-A110

Other Intervention Name(s)

Pagibaximab

Intervention Description

BSYX-A110, Dosed intravenously, 10 mg/kg

Primary Outcome Measure Information:

Title

To evaluate the safety and tolerability.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be 18 years of age or older. Subjects must in good general health, without significant medical history, physical examination findings or clinical laboratory abnormalities. Negative screening pre-treatment pregnancy test for female subjects. Subjects of childbearing potential must agree to use an acceptable method of contraception throughout the course of the study. All aspects of the protocol explained and written informed consent obtained. Exclusion Criteria: Known or suspected immunodeficiency (e.g. HIV infection, significant risk factors for HIV, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression. Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.). Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody. History of leukemia, lymphoma or other malignancy. Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test). Receipt of any vaccine within 30 days. History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study. Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date). Participation in another investigational drug or vaccine trial within 30 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonard Weisman, MD

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.biosynexus.com

Description

Biosynexus Incorporated

Learn more about this trial

Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants

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