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

NCT ID: NCT00636285

Last Updated: 2008-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2001-11-30

Brief Summary

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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

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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.

Conditions

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Staphylococcal Sepsis

Keywords

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A110 Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

2

BSYX-A110, Dosed intravenously, 3mg/kg

Group Type EXPERIMENTAL

BSYX-A110

Intervention Type DRUG

BSYX-A110, Dosed intravenously, 3 mg/kg

3

BSYX-A110, Dosed intravenously, 10mg/kg

Group Type EXPERIMENTAL

BSYX-A110

Intervention Type DRUG

BSYX-A110, Dosed intravenously, 10 mg/kg

Interventions

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Placebo

Placebo

Intervention Type DRUG

BSYX-A110

BSYX-A110, Dosed intravenously, 3 mg/kg

Intervention Type DRUG

BSYX-A110

BSYX-A110, Dosed intravenously, 10 mg/kg

Intervention Type DRUG

Other Intervention Names

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Pagibaximab BSYX-A110 Pagibaximab Pagibaximab

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.).
3. Serology positive for HIV, hepatitis B surface antigen or hepatitis C antibody.
4. History of leukemia, lymphoma or other malignancy.
5. Clinically significant cardiac, respiratory, renal, hepatic, neurological disorder
6. Pregnant or lactating females (women of childbearing potential will undergo a pregnancy test).
7. Receipt of any vaccine within 30 days.
8. 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.
9. Fever or acute illness within 3 days prior to treatment. (These subjects can be rescheduled for treatment at a later date).
10. Participation in another investigational drug or vaccine trial within 30 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biosynexus Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Biosynexus Incorporated

Principal Investigators

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Leonard Weisman, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Baylor College of Medicine

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.biosynexus.com

Biosynexus Incorporated

Other Identifiers

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MAB-A001

Identifier Type: -

Identifier Source: org_study_id