Respiratory Syncytial Virus InfectionsPhase 1NCT00192465
Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults
A Phase 1 study testing MEDI-524 (Numax-TM) in people with Respiratory Syncytial Virus Infections, run by MedImmune LLC at 1 site in United States.
Trial summary
To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- MEDI-524 (Numax-TM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Nov 2004
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must meet all of the following criteria:
- Age 18 through 49 years at the time of administration of study drug
- Weight £90 kg
- Healthy by medical history and physical examination
- Normal electrocardiogram (EKG) at screening (must be within 21 days before entry into the study)
- Written informed consent obtained from the volunteer
- Sexually active females, unless surgically sterile, must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 14 days prior to the administration of study drug, must agree to continue using such precautions for 30 days after administration of study drug, and must have a negative serum pregnancy test within 7 days prior to the administration of study drug and a negative urine pregnancy test on the day of study drug administration.
- Ability to complete the follow-up period of 90 days (single-dose groups) or 120 days (two-dose group) as required by the protocol
Who cannot join
- Volunteers must have none of the following:
- Acute illness at the time of entry into the study
- Temperature ³99.5°F at the time of entry into the study
- Any drug therapy within 7 days prior to Study Day 0 (except for certain medications such as contraceptives, topical corticosteroids, or infrequent use of over-the-counter headache medications, following approval of the sponsor)
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
- Receipt of immunoglobulin or blood products within 60 days before entry into the study
Show all 16Show fewer
- Receipt of any investigational drug therapy or standard vaccine within 120 days before administration of study drug in this protocol through 60 days after the final dose of study drug
- History of immunodeficiency or receipt of immunosuppressive drugs
- History of allergic disease or reactions likely to be exacerbated by any component of the study drug
- Previous medical history or evidence of an intercurrent illness that may compromise the safety of the volunteer in the study
- Evidence of any systemic disease on physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- At screening (must be within 7 days before study dose administration) any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count < 120,000/mm3 (or laboratory normal values); AST, ALT, BUN, creatinine > upper limit of normal; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant.
- Nursing mother
- History of alcohol or drug abuse within the past 2 years
- The presence of any condition or concern which in the opinion of the principal investigator may interfere with the conduct or interpretation of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 (NUMAX TM), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Healthy Adults
To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- MEDI-524 (Numax-TM)
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-524 (Numax-TM)Biological
Grp.1: 3 mg/kg IV (single dose)
MEDI-524 (Numax-TM)Biological
Grp. 2: 15 mg/kg IV (single dose)
MEDI-524 (Numax-TM)Biological
Grp. 3: 30 mg/kg IV (single dose)
MEDI-524 (Numax-TM)Biological
Grp. 4: 3 mg/kg IM (single dose)
MEDI-524 (Numax-TM)Biological
Grp.5: 3 mg/kg IM (two doses)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-524 (Numax-TM) Receives: Biological: MEDI-524 (Numax-TM) |
| 2 | Experimental | MEDI-524 (Numax-TM) Receives: Biological: MEDI-524 (Numax-TM) |
| 3 | Experimental | MEDI-524 (Numax-TM) Receives: Biological: MEDI-524 (Numax-TM) |
| 4 | Experimental | MEDI-524 (Numax-TM) Receives: Biological: MEDI-524 (Numax-TM) |
| 5 | Experimental | MEDI-524 (Numax-TM) Receives: Biological: MEDI-524 (Numax-TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 30 days after patient's final dose of study drug
Pharmacokinetics
Measured: Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2.
Immunogenicity
Measured: 150 days after final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionApr 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Genevieve Losonsky, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192465
- Sponsor's protocol ID
- MI-CP101
- Status last verified
- Jan 2009
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 (NUMAX TM), a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Healthy Adults
- ClinicalTrials.gov ID
- NCT00192465
- Acronym / sponsor ID
- MI-CP101
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 19 Sep 2005 (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 provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524 administered initially as a single dose to healthy adults in a dose escalation safety study before testing in the targeted pediatric population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MEDI-524 (Numax-TM)MEDI-524 (Numax-TM) |
| 2 | Experimental | Biological: MEDI-524 (Numax-TM)MEDI-524 (Numax-TM) |
| 3 | Experimental | Biological: MEDI-524 (Numax-TM)MEDI-524 (Numax-TM) |
| 4 | Experimental | Biological: MEDI-524 (Numax-TM)MEDI-524 (Numax-TM) |
| 5 | Experimental | Biological: MEDI-524 (Numax-TM)MEDI-524 (Numax-TM) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Volunteers must meet all of the following criteria:
- Age 18 through 49 years at the time of administration of study drug
- Weight £90 kg
- Healthy by medical history and physical examination
- Normal electrocardiogram (EKG) at screening (must be within 21 days before entry into the study)
Key exclusion criteria (16 listed)
- Volunteers must have none of the following:
- Acute illness at the time of entry into the study
- Temperature ³99.5°F at the time of entry into the study
- Any drug therapy within 7 days prior to Study Day 0 (except for certain medications such as contraceptives, topical corticosteroids, or infrequent use of over-the-counter headache medications, following approval of the sponsor)
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
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-524 (Numax-TM)Grp.1: 3 mg/kg IV (single dose) | Biological | 1 |
| MEDI-524 (Numax-TM)Grp. 2: 15 mg/kg IV (single dose) | Biological | 2 |
| MEDI-524 (Numax-TM)Grp. 3: 30 mg/kg IV (single dose) | Biological | 3 |
| MEDI-524 (Numax-TM)Grp. 4: 3 mg/kg IM (single dose) | Biological | 4 |
| MEDI-524 (Numax-TM)Grp.5: 3 mg/kg IM (two doses) | Biological | 5 |
Primary outcome
Safety
Time frame: 30 days after patient's final dose of study drug
Pharmacokinetics
Time frame: Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2.
Immunogenicity
Time frame: 150 days after final 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 29 Jan 2009.
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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.
Genevieve Losonsky, MD 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-524 (Numax-TM) in people with Respiratory Syncytial Virus Infections, 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 16 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 29 Jan 2009. 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?
Safety (time frame: 30 days after patient's final dose of study drug). 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 29 Jan 2009.