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

NCT00636285 | Completed Phase 1

• 1 other identifier: MAB-A001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcal Sepsis

Keywords

A110; Safety

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability.

  28 days

Secondary Outcomes (1)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

BSYX-A110, Dosed intravenously, 3mg/kg

Drug: BSYX-A110

3

EXPERIMENTAL

BSYX-A110, Dosed intravenously, 10mg/kg

Drug: BSYX-A110

Interventions

Placebo DRUG

Placebo

Also known as: Pagibaximab, BSYX-A110

1

BSYX-A110 DRUG

BSYX-A110, Dosed intravenously, 3 mg/kg

Also known as: Pagibaximab

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biosynexus Incorporated: lead

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

• Biosynexus Incorporated

MeSH Terms

Interventions

pagibaximab

Study Officials

• Leonard Weisman, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 14, 2008
• Study Start: April 1, 2001
• Primary Completion: September 1, 2001
• Study Completion: November 1, 2001
• Last Updated: October 9, 2008

Record last verified: 2008-10

Locations

US (1)