A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Study identifier:CD-RI-MEDI7814-1027
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers
Medical condition
Healthy subjects
Phase
Phase 1
Healthy volunteers
Yes
Study drug
MEDI7814
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 49 Years
Date
Study Start Date: 01 Feb 2012
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Nov 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2012 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Cohort 1 Dose level 1 | Drug: MEDI7814 MEDI7814 is a human immunoglobulin G4 (IgG4), effector-null, neutralizing monoclonal antibody (MAb) that is specific for human complement components C5, C5a, and C5a desArg, and prevents the binding of C5a to its receptors C5aR and C5L2. Other Name: none |
| Placebo Comparator: Cohort 2 Dose level 2 | Drug: MEDI7814 MEDI7814 is a human immunoglobulin G4 (IgG4), effector-null, neutralizing monoclonal antibody (MAb) that is specific for human complement components C5, C5a, and C5a desArg, and prevents the binding of C5a to its receptors C5aR and C5L2. Other Name: none |
| Placebo Comparator: Cohort 3 Dose level 3 | Drug: MEDI7814 MEDI7814 is a human immunoglobulin G4 (IgG4), effector-null, neutralizing monoclonal antibody (MAb) that is specific for human complement components C5, C5a, and C5a desArg, and prevents the binding of C5a to its receptors C5aR and C5L2. Other Name: none |
| Placebo Comparator: Cohort 4 Dose level 4 | Drug: MEDI7814 MEDI7814 is a human immunoglobulin G4 (IgG4), effector-null, neutralizing monoclonal antibody (MAb) that is specific for human complement components C5, C5a, and C5a desArg, and prevents the binding of C5a to its receptors C5aR and C5L2. Other Name: none |
Contacts
Investigators
Principal Investigator
Alan Marion
Research site
