HealthyPhase 1NCT00578682
A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
A Phase 1 study testing MEDI-557 in people with Healthy, run by MedImmune LLC at 1 site in United States.
Trial summary
To evaluate the safety and tolerability of a single IV dose of MEDI-557. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MEDI-557
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Nov 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 through 45 years at the time of study entry;
- Weight ≤ 90 kg;
- Healthy by medical history and physical examination;
- Normotensive (systolic blood pressure [BP] < 150 mmHg and diastolic BP <90 mmHg);
- Normal electrocardiogram (ECG) at screening (must occur within 21 days before entry into the study);
- Normal spirometry at screening (must occur within 21 days before entry into the study). Normal spirometry is defined as FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) ≥ 80% predicted and an FEV1/FVC > 70%.
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- Written informed consent obtained from the subject;
- Sexually active females, unless surgically sterile, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner or sterile sexual partner) for 14 days prior to study drug dosing, must agree to continue using such precautions for 1 year after administration of study drug, and must have a negative serum pregnancy test within 3 days prior to study drug dosing and a negative urine pregnancy test on the day of study drug administration; and
- Ability to complete follow-up period of 240 days as required by the protocol.
Who cannot join
- Acute illness at study entry;
- Fever ≥ 99.5°F at study entry;
- Any drug therapy within 7 days prior to Study Day 0 (except contraceptives);
- Blood donation in excess of 400 mL within 6 months prior to study entry;
- Receipt of immunoglobulin or blood products within 60 days prior to study entry;
- Receipt of any investigational drug therapy or standard vaccine within 120 days prior to study drug dosing through 240 days after study drug dosing;
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- Previous receipt of palivizumab or motavizumab; History of immunodeficiency;
- History of allergic disease or reactions likely to be exacerbated by any component of either study drug;
- 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;
- Evidence of infection (ie, positive laboratory test result) with hepatitis A, B, or C virus or human immunodeficiency virus-1 (HIV-1);
- At screening (must be within 21 days before entry into the study) any of the following: hemoglobin < 12.0 gm/dL, white blood cell count (WBC) < 4,000/mm3, platelet count < 120,000/mm3 (or laboratory normal values); aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), serum creatinine > upper limit of normal (ULN); other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to be clinically significant; other abnormal laboratory values in the screening panel which, in the opinion of the principal investigator, are judged to potentially confound analysis of study results;
- Pregnancy, or nursing mother;
- History of alcohol or drug abuse within the past 2 years; or
- History of asthma, seasonal allergies, or exercise-induced wheezing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557, A Humanized Monoclonal Antibody With an Extended Half-Life Against Respiratory Syncytial Virus (RSV), in Healthy Adults
To evaluate the safety and tolerability of a single IV dose of MEDI-557.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of a single IV dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.
- Conditions
- Healthy
- Being tested
- MEDI-557
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-557Biological
Also called motavizumab
Single IV dose of 3 mg/kg
MEDI-557Biological
Also called motavizumab
Single IV dose of 15 mg/kg
MEDI-557Biological
Also called motavizumab
Single IV dose of 30 mg/kg
MEDI-557Biological
Single IV dose of 0.3 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single IV dose of 0.3 mg/kg MEDI-557 Receives: Biological: MEDI-557 |
| 2 | Experimental | Single IV dose of 3 mg/kg MEDI-557 Receives: Biological: MEDI-557 |
| 3 | Experimental | Single IV dose of 15 mg/kg MEDI-557 Receives: Biological: MEDI-557 |
| 4 | Experimental | Single IV dose of 30 mg/kg MEDI-557 Receives: Biological: MEDI-557 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of AEs from the period immediately following study drug administration
Measured: through 28 days after dosing
The occurrence of laboratory AEs from the period immediately following study drug administration
Measured: through 90 days after dosing
The occurrence of SAEs from the period immediately following study drug administration
Measured: through 240 days after dosing
Secondary outcomes (1)
The single-dose pharmacokinetic parameters of IV MEDI-557 and motavizumab monitored using noncompartmental analysis.
Measured: Day 240
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M. Pamela Griffin, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578682
- Sponsor's protocol ID
- MI-CP144
- Status last verified
- Nov 2011
- First submitted
- 19 Dec 2007
- Last updated
- 23 Nov 2011
- Results posted
- No
Publications
Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.
PubMed 24080653
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557, A Humanized Monoclonal Antibody With an Extended Half-Life Against Respiratory Syncytial Virus (RSV), in Healthy Adults
- ClinicalTrials.gov ID
- NCT00578682
- Acronym / sponsor ID
- MI-CP144
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Dec 2007 (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.
To evaluate the safety and tolerability of a single IV dose of MEDI-557.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of a single IV dose of MEDI-557 administered to healthy adult subjects in 4 dose cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MEDI-557Single IV dose of 0.3 mg/kg MEDI-557 |
| 2 | Experimental | Biological: MEDI-557Single IV dose of 3 mg/kg MEDI-557 |
| 3 | Experimental | Biological: MEDI-557Single IV dose of 15 mg/kg MEDI-557 |
| 4 | Experimental | Biological: MEDI-557Single IV dose of 30 mg/kg MEDI-557 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 through 45 years at the time of study entry;
- Weight ≤ 90 kg;
- Healthy by medical history and physical examination;
- Normotensive (systolic blood pressure [BP] < 150 mmHg and diastolic BP <90 mmHg);
- Normal electrocardiogram (ECG) at screening (must occur within 21 days before entry into the study);
Key exclusion criteria (15 listed)
- Acute illness at study entry;
- Fever ≥ 99.5°F at study entry;
- Any drug therapy within 7 days prior to Study Day 0 (except contraceptives);
- Blood donation in excess of 400 mL within 6 months prior to study entry;
- Receipt of immunoglobulin or blood products within 60 days prior to study entry;
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 |
|---|---|---|
| MEDI-557Also: motavizumabSingle IV dose of 3 mg/kg | Biological | 2 |
| MEDI-557Also: motavizumabSingle IV dose of 15 mg/kg | Biological | 3 |
| MEDI-557Also: motavizumabSingle IV dose of 30 mg/kg | Biological | 4 |
| MEDI-557Single IV dose of 0.3 mg/kg | Biological | 1 |
Primary outcome
The occurrence of AEs from the period immediately following study drug administration
Time frame: through 28 days after dosing
The occurrence of laboratory AEs from the period immediately following study drug administration
Time frame: through 90 days after dosing
The occurrence of SAEs from the period immediately following study drug administration
Time frame: through 240 days after dosing
1 secondary outcome
The single-dose pharmacokinetic parameters of IV MEDI-557 and motavizumab monitored using noncompartmental analysis.
Time frame: Day 240
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 23 Nov 2011.
- Derived from this study: PubMed 24080653Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP. A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults. Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.
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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.
M. Pamela Griffin, 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 MEDI-557 in people with Healthy, 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 9 inclusion and 15 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 23 Nov 2011. 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. 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 occurrence of AEs from the period immediately following study drug administration (time frame: through 28 days after dosing). 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?
On the ClinicalTrials.gov record for NCT00578682, which also lists 1 linked publication.
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 23 Nov 2011.