Respiratory Syncytial VirusPhase 1CD-1092NCT01562938
MEDI-557 Adult Dosing
A Phase 1 study testing MEDI-557 in people with Respiratory Syncytial Virus, run by MedImmune LLC at 1 site in United States.
Trial summary
This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- MEDI-557
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 2013
- 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
- 18-45 years
- written informed consent obtained from subject prior to performing any protocol related procedures
- healthy by medical history and physical exam
- females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug
- nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361
- weight </= 110kg with a body mass index of <32kg/m2
- ability to complete a follow-up period of approximately 360 days
Who cannot join
- inability to complete a follow-up period of 360 days
- any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results
- concurrent enrollment in another clinical study
- employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals
- receipt of immunoglobulin or blood products within 60 days prior to randomziation
- receipt of any investigational drug therapy within 6 months prior to IP dosing
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- clinically abnormal ECG at screening
- blood donation in excess of 400mL, wihtin 6 months prior to randomization
- previous receipt fo biologics
- history of immunodeficiency
- history of allergic disease or reactions likely to be exacerbated by any component of the IP
- previous medical history or evidence of interurrent illness that may compromise the safety of the subject
- positive lab test for Hep A, B, C or HIV
- pregnancy or nursing mother
- history of alcohol or drug abuse within past 2 years
- positive urine Class A drug screen
- acute illness within 7 days prior to randomization
- fever >/= 99.5F witin 7 days prior to randomization
- any drug therapy within 7 days prior to randomization
- systolic BP >150mmHG and/or diastolic BP>90mmHg
- receipt of vaccine within 14 days prior to randomization
- abnormal study labs (hem/wbc/platelet/BUN - see protocol for specific information)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults
This is a Phase 1, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
Read the detailed description
A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Placebo, MEDI-557
- Keywords
- Respiratory Syncytial Virus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
MEDI-557Drug
MEDI-557 low-dose
MEDI-557Drug
MEDI-557 high-dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| MEDI-557 low-dose | Active comparator | Not described Receives: Drug: MEDI-557 |
| MEDI-557 high-dose | Active comparator | Not described Receives: Drug: MEDI-557 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The occurrence of AEs and SAEs
Measured: from time of informed consent through 360 days post dose (approximately 1 year total)
Safety and Tolerability
Vital sign measurements - blood pressure, heart rate, respiratory rate, temperature
Measured: Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion
Safety and Tolerability
Clinical lab measurements - chemistry, hematology; Urinalysis
Measured: from Day 1 (pre-dose) through 360 days post dose.
Secondary outcomes (4)
Pharmacokinetic Assessments - Serum
Maximum serum concentration; Time to maximum serum concentration; Terminal phase elimination half-life; Area under the serum concentration-time curve from time zero to last measurable time point; Area under the serum concentration-time curve from time zero to infinity; Clearance; Volume of distribution
Measured: 1st dose through 360 days post dose
Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash
MEDI-557 concentrations in serum and nasal wash through 360 days post dose
Measured: 1st dose through 360 days post dose
Pharmacokinetic Assessments - Nasal Wash
Maximum nasal wash concentration; Time to maximum nasal wash concentration; Area under the nasal wash conentration-time curve from time zero to last measurable time point
Measured: 1st dose through 360 days post dose
anti-RSV antibody in Serum and Nasal Wash
To evaluate anti-RSV antibodies (F-specific IgG and neutralizing) in serum and nasal wash.
Measured: 1st 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 posted26 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Feldman, MD, Principal investigator, Research SiteHasan Jafri, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562938
- Sponsor's protocol ID
- CD-ID-MEDI-557-1092
- Acronym
- CD-1092
- Status last verified
- Oct 2013
- First submitted
- 7 Mar 2012
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of MEDI-557, a Humanized Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus (RSV), Administered to Healthy Adults
- ClinicalTrials.gov ID
- NCT01562938
- Acronym / sponsor ID
- CD-1092 / CD-ID-MEDI-557-1092
- Conditions
- Respiratory Syncytial Virus
- Keywords
- Respiratory Syncytial Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Mar 2012 (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, double-blind, placebo controlled study enrolling 42 healthy adult subjects (18-45yrs) from 1 site. Subjects will be randomized in a 2:3:2 ratio to receive MEDI-557 or placebo. Subjects will receive 1 intravenous dose on Study Day 1. Subjects will be followed for safety from the time of Informed Consent through 360 days post dose.
Detailed description
A Phase 1, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of MEDI-557 administered IV to healthy adult subjects (18-45yrs). A maximum of 42 subjects from 1 site will be enrolled in a 2:3:2 ratio (12 placebo, 18 MEDI-557 low-dose, 12 MEDI-557 high-dose) to allow for greater data collection in the low-dose group. Subjects are evaluated for safety from time of Informed Consent through Study Day 360 post dose.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| MEDI-557 low-dose | Active comparator | Drug: MEDI-557 |
| MEDI-557 high-dose | Active comparator | Drug: MEDI-557 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-45 years
- written informed consent obtained from subject prior to performing any protocol related procedures
- healthy by medical history and physical exam
- females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and through 1 year after administration of study drug
- nonsterilized, sexually active males with female partner of child-bearing potential must use 2 effective methods of birth control from Day 1 through Day 361
Key exclusion criteria (22 listed)
- inability to complete a follow-up period of 360 days
- any condition in the opinion of investigator that would interfere with evaluation of IP or interpretation of subject safety or study results
- concurrent enrollment in another clinical study
- employees of the site or other individuals involved with the conduct of the study or immediate family members of such individuals
- receipt of immunoglobulin or blood products within 60 days prior to randomziation
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 |
| MEDI-557MEDI-557 low-dose | Drug | MEDI-557 low-dose |
| MEDI-557MEDI-557 high-dose | Drug | MEDI-557 high-dose |
Primary outcome
Safety and Tolerability
Time frame: from time of informed consent through 360 days post dose (approximately 1 year total)
The occurrence of AEs and SAEs
Safety and Tolerability
Time frame: Pre-dose; every 30 minutes during infusion; up to 24 hours after end of infusion
Vital sign measurements - blood pressure, heart rate, respiratory rate, temperature
Safety and Tolerability
Time frame: from Day 1 (pre-dose) through 360 days post dose.
Clinical lab measurements - chemistry, hematology; Urinalysis
4 secondary outcomes
Pharmacokinetic Assessments - Serum
Time frame: 1st dose through 360 days post dose
Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash
Time frame: 1st dose through 360 days post dose
Pharmacokinetic Assessments - Nasal Wash
Time frame: 1st dose through 360 days post dose
anti-RSV antibody in Serum and Nasal Wash
Time frame: 1st 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 7 Oct 2013.
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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.
Robert Feldman, MD principal investigator
Research Site
Hasan Jafri 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 Respiratory Syncytial Virus, 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 7 inclusion and 22 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 7 Oct 2013. 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?
Safety and Tolerability (time frame: from time of informed consent through 360 days post dose (approximately 1 year total)). 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 7 Oct 2013.