Staphylococcus AureusPhase 1NCT01769417
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects
A Phase 1 study testing MEDI4893 in people with Staphylococcus Aureus, run by MedImmune LLC at 1 site in United States.
Trial summary
This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- MEDI4893
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2014
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 through 65 years at screening.
- Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Females of childbearing age using contraception for at least 28 days prior to receiving the dose of investigational product, and for 1 year after receiving IP.
- Weight ≥ 45 kg and ≤ 110 kg at screening.
- Healthy by medical history and physical examination at screening.
- Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg at screening.
- Normal electrocardiogram (ECG) at screening.
- Able to complete the 360-day postdose follow-up period as required by the protocol.
Who cannot join
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Acute illness at study entry.
- Fever 99.5F or higher on day of dosing.
- Any drug therapy within 7 days prior to Day 1.
- Blood donation in excess of 400 mL within 6 months prior to study entry.
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- Receipt of immunoglobulin or blood products within 6 months prior to study entry.
- Receipt of any prior investigational drug or investigational vaccine within 120 days prior to investigational product dosing or planned dosing
- Receipt of any standard vaccine within 14 days prior to investigational product dosing.
- Previous receipt of a monoclonal antibody.
- Receipt of immunosuppressive medications in the prior year or any active or prior history of immunodeficiency. Any course of systemic corticosteroids of more than 7 day duration during the prior year excludes a subject.
- History of allergic disease or reactions likely to be exacerbated by any component of the investigational product.
- Previous medical history or evidence of an intercurrent illness that may compromise the safety of the subject in the study.
- Evidence of any systemic disease on physical examination at screening.
- Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus (HIV) at screening.
- Any of the following at screening:
- Hemoglobin < 12.0 g/dL for males and < 11.5 g/dL for females.
- WBC count < 3,800/mm3.
- Platelet count < 140,000/mm3.
- AST, ALT, BUN, serum creatinine > upper limit of normal (ULN).
- Positive Urine Class A drug screen.
- Other abnormal laboratory values in the screening panel, which in the opinion of the principal investigator, are judged to be clinically significant or potentially confound study results.
- Pregnant or nursing mother.
- Active alcohol or drug abuse or history of alcohol or drug abuse that, in the opinion of the principal investigator, might compromise subject safety, study safety assessments, or ability of subject to comply with study requirements.
- Concurrent enrollment in another interventional study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Extended Half-Life Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin, in Healthy Adult Subjects
This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
Read the detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI4893, an extended half-life human monoclonal antibody against Staphylococcus aureus alpha toxin, in healthy adult subjects. Approximately 33 subjects will be enrolled across 4 fixed dose cohorts at 1 study site . This study will last approximately 389 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 360 day safety follow up period.
- Conditions
- Staphylococcus Aureus
- Being tested
- Placebo, MEDI4893
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
MEDI4893Drug
Also called Active comparator
Human immunoglobulin G1 kappa monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| MEDI4893 | Active comparator | Not described Receives: Drug: MEDI4893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of adverse events and serious adverse events.
Measured: From the time of informed consent through 360 days post dose
Vital Sign Measurements
blood pressure, heart rate, respiratory rate, temperature
Measured: Pre-dose through Study Day 15
Clinical Safety lab measurements
Chemistry, Hematology and urinalysis
Measured: from Day 1 (pre-dose) through 90 days post dose
Secondary outcomes (2)
Pharmacokinetic Assessments - Serum
MEDI4893 Pharmacokinetic parameters.
Measured: Pre-dose through 360 days post dose
Anti Drug Antibody (ADA) Assessments - Serum
ADA responses to MEDI4893.
Measured: Pre-dose through 360 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Schwartz, M.D., Principal investigator, Research SiteHasan Jafri, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769417
- Sponsor's protocol ID
- CD-ID-MEDI4893-1133
- Status last verified
- Jul 2014
- First submitted
- 11 Jan 2013
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Extended Half-Life Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01769417
- Acronym / sponsor ID
- CD-ID-MEDI4893-1133
- Conditions
- Staphylococcus Aureus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Jan 2013 (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.
This is a Phase 1, first time in human study enrolling approximately 33 healthy adult subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
Detailed description
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of MEDI4893, an extended half-life human monoclonal antibody against Staphylococcus aureus alpha toxin, in healthy adult subjects. Approximately 33 subjects will be enrolled across 4 fixed dose cohorts at 1 study site . This study will last approximately 389 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 360 day safety follow up period.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| MEDI4893 | Active comparator | Drug: MEDI4893 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 through 65 years at screening.
- Written informed consent and any locally required authorization (eg, HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Females of childbearing age using contraception for at least 28 days prior to receiving the dose of investigational product, and for 1 year after receiving IP.
- Weight ≥ 45 kg and ≤ 110 kg at screening.
- Healthy by medical history and physical examination at screening.
Key exclusion criteria (25 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
- Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Acute illness at study entry.
- Fever 99.5F or higher on day of dosing.
- Any drug therapy within 7 days prior to Day 1.
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 |
|---|---|---|
| PlaceboPlacebo | Drug | Placebo |
| MEDI4893Also: Active comparatorHuman immunoglobulin G1 kappa monoclonal antibody | Drug | MEDI4893 |
Primary outcome
The occurence of adverse events and serious adverse events.
Time frame: From the time of informed consent through 360 days post dose
Vital Sign Measurements
Time frame: Pre-dose through Study Day 15
blood pressure, heart rate, respiratory rate, temperature
Clinical Safety lab measurements
Time frame: from Day 1 (pre-dose) through 90 days post dose
Chemistry, Hematology and urinalysis
2 secondary outcomes
Pharmacokinetic Assessments - Serum
Time frame: Pre-dose through 360 days post dose
Anti Drug Antibody (ADA) Assessments - Serum
Time frame: Pre-dose through 360 days post dose
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 24 Jul 2014.
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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.
Howard Schwartz, M.D. principal investigator
Research Site
Hasan Jafri, M.D. study director
MedImmune LLC
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 MEDI4893 in people with Staphylococcus Aureus, run by MedImmune LLC 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 8 inclusion and 25 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 24 Jul 2014. 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?
The occurence of adverse events and serious adverse events. (time frame: From the time of informed consent through 360 days post dose). The study lists 3 primary outcomes in all. 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 24 Jul 2014.