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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01544361
First received: February 15, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a Phase 1, study to evaluate the safety and tolerability of single ascending IV doses of MEDI7814 in healthy adult subjects.


Condition Intervention Phase
Healthy Subjects
 Drug: MEDI7814
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety and Tolerability - Analysis of treatment emergent events. [ Time Frame: Day 106 post dosing ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to evaluate the safety and tolerability of single ascending IV doses of MEDI7814 in healthy adult subjects, which will be assessed primarily by summarizing treatment-emergent AEs and SAEs. The occurance of treatment emergent AEs and SAEs will be collected and summarized from the commencement of infustion of investigational product through the end of the study. Treatment emergent events will be summarized by system organ class and preferred terms, by severity, and relationship to the investigational product.


Secondary Outcome Measures:
  • Pharmacokinetics of MEDI7814 [ Time Frame: Day 106 post dosing ] [ Designated as safety issue: No ]
    Individual MEDI7814 plasma concentration data will be tabulated by treatment group along with descriptive statistics. Noncompartmental PK data analysis will be performed for MEDI7814-treated subjects to estimate PK parameters if data allow. Descriptive statistics of the PK parameters will be provided by treatment group.

  • Immunogenicity of MEDI7814 [ Time Frame: Day 106 post dosing ] [ Designated as safety issue: No ]
    The presence of ADAs against MEDI7814 will be assessed. Results will be analyzed by summarizing the number and percentage of subjects that are ADA positive and titer by treatment group. The ADA results for each individual will be listed. The impact of ADA on PK and association with AEs and SAEs will be assessed if data allow.


Enrollment: 32
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.
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.
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.
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.

Detailed Description:

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of single ascending IV doses of MEDI7814 in healthy adult male subjects and female subjects of nonchildbearing potential.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Aged 18 years up to and including 70 years at the time of first dose of investigational product.

Healthy by medical history, physical examination, and laboratory studies.;Body weight 50-125 kg.;Body mass index 19.0-32.0 kg/m2 (inclusive); Females must be of nonchildbearing potential Exclusion criteria -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;Use of immunosuppressive medications; Subjects who have an unresolved infection with any Neisseria species;Subjects who have had their spleen removed for any reason.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544361

Locations
United States, Nebraska
Research Site
Omaha, Nebraska, United States
Sponsors and Collaborators
MedImmune LLC
Investigators
Principal Investigator: Alan Marion, MD Research site
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01544361     History of Changes
Other Study ID Numbers: CD-RI-MEDI7814-1027
Study First Received: February 15, 2012
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
FTiH

ClinicalTrials.gov processed this record on May 19, 2013