A Phase 1 Study to Evaluate the Safety of MEDI7814 in Adult Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Placebo; Biological: MEDI7814, 1 MG/KG; Biological: MEDI7814, 3 MG/KG; Biological: MEDI7814, 10 MG/KG; Biological: MEDI7814, 20 MG/KG

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	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.	Day 1 to Day 106

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameters of MEDI7814	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.	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
Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814		Day 1, 29, 57, 85, and 106

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Principal Investigator: Alan Marion, MD, Research Site

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Healthy subjects; MEDI7814; FTiH
• Other Study ID Numbers: CD-RI-MEDI7814-1027