Healthy SubjectsPhase 1NCT01544361
A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
A Phase 1 study testing MEDI7814, 1 MG/KG, MEDI7814, 3 MG/KG and MEDI7814, 10 MG/KG in people with Healthy Subjects, run by MedImmune LLC at 1 site in United States.
Trial summary
This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- MEDI7814, 1 MG/KG, MEDI7814, 3 MG/KG and MEDI7814, 10 MG/KG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years up to and including 49 years at the time of first dose of investigational product
- Healthy by medical history, physical examination, and laboratory studies
- Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m^2) (inclusive)
- Females must be of non-childbearing potential.
Who cannot join
- Any acute illness within 30 days of screening
- Concurrent enrollment in another clinical trial
- The subject has a positive drug/alcohol screen at screening or Day -1
- Pregnancy
- Current cigarette smokers
- History of cancer other than non-melanoma skin cancer or in situ carcinoma of the cervix treated with apparent success
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- Use of immunosuppressive medications
- Subjects who have an unresolved infection with any Neisseria species
- Subjects who have had their spleen removed for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
This is a Phase 1 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.
- Conditions
- Healthy Subjects
- Being tested
- Placebo, MEDI7814, 1 MG/KG, MEDI7814, 3 MG/KG, MEDI7814, 10 MG/KG, MEDI7814, 20 MG/KG
- Keywords
- Healthy subjects, MEDI7814, FTiH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 1 MG/KGBiological
A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 3 MG/KGBiological
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 10 MG/KGBiological
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 20 MG/KGBiological
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. Receives: Other: Placebo |
| MEDI7814, 1 MG/KG | Experimental | A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. Receives: Biological: MEDI7814, 1 MG/KG |
| MEDI7814, 3 MG/KG | Experimental | A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. Receives: Biological: MEDI7814, 3 MG/KG |
| MEDI7814, 10 MG/KG | Experimental | A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. Receives: Biological: MEDI7814, 10 MG/KG |
| MEDI7814, 20 MG/KG | Experimental | A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. Receives: Biological: MEDI7814, 20 MG/KG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Measured: Day 1 to Day 106
Secondary outcomes (2)
Pharmacokinetic (PK) Parameters of MEDI7814
Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.
Measured: Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106
Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814
Measured: Day 1, 29, 57, 85, and 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy SubjectsStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Marion, MD, Principal investigator, Research site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544361
- Sponsor's protocol ID
- CD-RI-MEDI7814-1027
- Status last verified
- Jun 2014
- First submitted
- 15 Feb 2012
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
- ClinicalTrials.gov ID
- NCT01544361
- Acronym / sponsor ID
- CD-RI-MEDI7814-1027
- Conditions
- Healthy Subjects
- Keywords
- Healthy subjects, MEDI7814, FTiH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 23 Jul 2014
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 study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult subjects.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending intravenous doses of MEDI7814 in healthy adult male subjects and female subjects of non-childbearing potential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboA single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 1 MG/KG | Experimental | Biological: MEDI7814, 1 MG/KGA single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 3 MG/KG | Experimental | Biological: MEDI7814, 3 MG/KGA single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 10 MG/KG | Experimental | Biological: MEDI7814, 10 MG/KGA single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
| MEDI7814, 20 MG/KG | Experimental | Biological: MEDI7814, 20 MG/KGA single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 years up to and including 49 years at the time of first dose of investigational product
- Healthy by medical history, physical examination, and laboratory studies
- Body weight 50-125 kilogram (kg); body mass index 19.0-32.0 kilogram per square meter (kg/m^2) (inclusive)
- Females must be of non-childbearing potential.
Key exclusion criteria (9 listed)
- Any acute illness within 30 days of screening
- Concurrent enrollment in another clinical trial
- The subject has a positive drug/alcohol screen at screening or Day -1
- Pregnancy
- Current cigarette smokers
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 |
|---|---|---|
| PlaceboA single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1. | Other | Placebo |
| MEDI7814, 1 MG/KGA single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological | MEDI7814, 1 MG/KG |
| MEDI7814, 3 MG/KGA single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological | MEDI7814, 3 MG/KG |
| MEDI7814, 10 MG/KGA single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological | MEDI7814, 10 MG/KG |
| MEDI7814, 20 MG/KGA single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1. | Biological | MEDI7814, 20 MG/KG |
Primary outcome
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 to Day 106
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
2 secondary outcomes
Pharmacokinetic (PK) Parameters of MEDI7814
Time frame: Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106
Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814
Time frame: Day 1, 29, 57, 85, and 106
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alan Marion, MD principal investigator
Research site
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 MEDI7814, 1 MG/KG, MEDI7814, 3 MG/KG and MEDI7814, 10 MG/KG in people with Healthy Subjects, 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 4 inclusion and 9 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 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?
Yes. Results are posted in the registry (first posted 23 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 to Day 106). 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 23 Jul 2014.