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Completed

NCT Number: NCT01544361

A Phase 1 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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Omaha, Nebraska, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Other

A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.

MEDI7814, 1 MG/KG

Biological

A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.

MEDI7814, 3 MG/KG

Biological

A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.

MEDI7814, 10 MG/KG

Biological

A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.

MEDI7814, 20 MG/KG

Biological

A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.

Primary outcomes

  1. Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 to Day 106

    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 outcomes

  1. 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

    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.

  2. Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814

    Time frame: Day 1, 29, 57, 85, and 106

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2012
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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