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

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

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcal Sepsis
• Intervention / Treatment: Drug: Placebo; Drug: BSYX-A110; Drug: BSYX-A110

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 1; Placebo	Drug: Placebo; Placebo; Other Names: Pagibaximab; BSYX-A110
EXPERIMENTAL: 2; BSYX-A110, Dosed intravenously, 3mg/kg	Drug: BSYX-A110; BSYX-A110, Dosed intravenously, 3 mg/kg; Other Names: Pagibaximab; Drug: BSYX-A110; BSYX-A110, Dosed intravenously, 10 mg/kg; Other Names: Pagibaximab
EXPERIMENTAL: 3; BSYX-A110, Dosed intravenously, 10mg/kg	Drug: BSYX-A110; BSYX-A110, Dosed intravenously, 3 mg/kg; Other Names: Pagibaximab; Drug: BSYX-A110; BSYX-A110, Dosed intravenously, 10 mg/kg; Other Names: Pagibaximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and tolerability.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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	28 days

Collaborators and Investigators

• Sponsor: Biosynexus Incorporated

Publications and helpful links

Helpful Links

• Biosynexus Incorporated

Study record dates

Study Major Dates

• Study Start: April 1, 2001
• Primary Completion (ACTUAL): September 1, 2001
• Study Completion (ACTUAL): November 1, 2001

Study Registration Dates

• First Submitted: February 27, 2008
• First Submitted That Met QC Criteria: March 7, 2008
• First Posted (ESTIMATE): March 14, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 9, 2008
• Last Update Submitted That Met QC Criteria: October 8, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Safety; A110
• Additional Relevant MeSH Terms: Body Weight; Birth Weight; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: MAB-A001