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A Phase 1 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: June 23, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Other: Placebo
Biological: MEDI7814, 1 MG/KG
Biological: MEDI7814, 3 MG/KG
Biological: MEDI7814, 10 MG/KG
Biological: MEDI7814, 20 MG/KG
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel 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:
  • Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to Day 106 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814 [ Time Frame: Day 1, 29, 57, 85, and 106 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
Other: Placebo
A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
Experimental: 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.
Biological: MEDI7814, 1 MG/KG
A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Experimental: MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Biological: MEDI7814, 3 MG/KG
A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Experimental: MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Biological: MEDI7814, 10 MG/KG
A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Experimental: MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
Biological: MEDI7814, 20 MG/KG
A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.

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.

  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 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Healthy subjects
MEDI7814
FTiH

ClinicalTrials.gov processed this record on November 27, 2014