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

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Omaha, NE, United States

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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Sheila Dicostanza

clinicaltrialenquiries@medimmune.com

Investigators

Principal Investigator

Alan Marion

Research site

A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator