A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
NCT ID: NCT01544361
Last Updated: 2014-07-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
125 participants
INTERVENTIONAL
2012-01-31
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess the Safety of MEDI7836 in Healthy Adults.
NCT02388347
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
NCT02669667
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
NCT02151110
A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers
NCT02394314
Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults
NCT04785144
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Use of immunosuppressive medications
* Subjects who have an unresolved infection with any Neisseria species
* Subjects who have had their spleen removed for any reason.
18 Years
49 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alan Marion, MD
Role: PRINCIPAL_INVESTIGATOR
Research site
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Omaha, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CD-RI-MEDI7814-1027
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.