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

Staphylococcal Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636285
• Other study ID #: MAB-A001
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2008
• Last updated: October 8, 2008
• Start date: April 2001
• Est. completion date: November 2001

Study information

• Verified date: October 2008
• Source: Biosynexus Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2001
• Est. primary completion date: September 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia
• Birth Weight
• Staphylococcal Infections
• Staphylococcal Sepsis

Intervention

Drug:
• Placebo
Placebo
• BSYX-A110
BSYX-A110, Dosed intravenously, 3 mg/kg
• BSYX-A110
BSYX-A110, Dosed intravenously, 10 mg/kg

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biosynexus Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability.		28 days	Yes
Secondary	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	Yes