Staphylococcal SepsisPhase 1NCT00636285
Safety and Pharmacokinetics Study in Adults for the Prevention of S. Epidermidis Infection in Low Birth Weight Infants
A Phase 1 study testing BSYX-A110 in people with Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Sepsis
- What is being tested?
- BSYX-A110
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Nov 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Staphylococcal Sepsis
- Being tested
- Placebo, BSYX-A110
- Keywords
- A110, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Pagibaximab, BSYX-A110
Placebo
BSYX-A110Drug
Also called Pagibaximab
BSYX-A110, Dosed intravenously, 3 mg/kg
BSYX-A110Drug
Also called Pagibaximab
BSYX-A110, Dosed intravenously, 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Experimental | BSYX-A110, Dosed intravenously, 3mg/kg Receives: Drug: BSYX-A110 |
| 3 | Experimental | BSYX-A110, Dosed intravenously, 10mg/kg Receives: Drug: BSYX-A110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability.
Measured: 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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startApr 2001
- Primary completionSep 2001
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosynexus Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leonard Weisman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636285
- Sponsor's protocol ID
- MAB-A001
- Status last verified
- Oct 2008
- First submitted
- 27 Feb 2008
- Last updated
- 9 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00636285
- Acronym / sponsor ID
- MAB-A001
- Conditions
- Staphylococcal Sepsis
- Keywords
- A110, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Biosynexus IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Sep 2001 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Experimental | Drug: BSYX-A110BSYX-A110, Dosed intravenously, 3mg/kg |
| 3 | Experimental | Drug: BSYX-A110BSYX-A110, Dosed intravenously, 10mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Pagibaximab, BSYX-A110Placebo | Drug | 1 |
| BSYX-A110Also: PagibaximabBSYX-A110, Dosed intravenously, 3 mg/kg | Drug | 2 |
| BSYX-A110Also: PagibaximabBSYX-A110, Dosed intravenously, 10 mg/kg | Drug | 3 |
Primary outcome
To evaluate the safety and tolerability.
Time frame: 28 days
1 secondary outcome
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
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Weisman, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BSYX-A110 in people with Staphylococcal Sepsis, run by Biosynexus Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2008.