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Completed

NCT Number: NCT02394314

A Phase 1, Single Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

A Phase 1, single dose study with 8 cohorts of ascending doses designed to evaluate the safety and pharmacokinetics of MEDI0382 in healthy volunteers.

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Key information

Conditions

Healthy Volunteers Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

About this study

This is a first-time-in-humans (FTIH), randomized, double-blind study designed to evaluate the safety, tolerability, and PK of MEDI0382 administered as single-ascending SC doses to healthy subjects (age 18-45). Eight subjects per cohort will be enrolled in a total of 8 cohorts. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee (DEC). Within each cohort, the subjects will be randomized to MEDI0382 or placebo (3:1). Following screening, the study duration for each subject will be approximately 29 days, consisting of an inpatient evaluation period, and an outpatient follow-up period.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Volunteers, ages 18-45
  • Must provide written informed consent
  • BMI >22 and <30 kg/m2 and body weight >70kg
  • Venous access suitable for multiple cannulations
  • Vital signs within normal specified ranges
  • Females must be non-lactating and non-childbearing potential
  • Males must practice 2 effective contraceptive measures if sexually active

Exclusion criteria

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • History of cancer, with the exception of non-melanoma skin cancer
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
  • Positive Hepatitis B, Hepatitis C or HIV test or use of antiretroviral medications at screening.
  • Concurrent or previous use of a GLP-1 receptor agonist
  • Current or previous use of systemic corticosteroids within the past 28 days prior to screening
  • Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
  • Known or suspected history of alcohol or drug abuse within the past 3 years.
  • Positive drug screen
  • Current smoker

Treatment and study plan

MEDI0382

Drug

MEDI0382 administered subcutaneously

Placebo

Drug

Placebo administered subcutaneously

Primary outcomes

  1. Number of subjects with adverse events as a measure of safety and tolerability of MEDI0382

    Time frame: 28 days post dosing

    Treatment emergent adverse events (TEAEs) and serious adverse events (STEAEs)

  2. Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    Time frame: 28 days post dosing

    GI symptomatology (a composite of nausea and vomiting)

  3. Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    Time frame: 28 days post dosing

    Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rate)

  4. Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    Time frame: 28 days post dosing

    12 lead electrocardiogram including RR, PR, QRS, QT and QTc intervals

  5. Number of subjects with Adverse events as a measure of safety and tolerability of MEDI0382

    Time frame: 28 days post dosing

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

Secondary outcomes

  1. Pharmacokinetics of MEDI0382, maximum plasma concentration (Cmax)

    Time frame: 72 hours postdose

    This variable will be estimated for MEDI0382 where the data allow.

  2. Pharmacokinetics of MEDI0382, area under the curve concentration (AUC)

    Time frame: 72 hours post dose

    This variable will be estimated for MEDI0382 where the data allow.

  3. Proportion of subjects with ADA to MEDI0382

    Time frame: 28 days post dose

    This variable will be estimated for MEDI0382 where the data allow.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1, Single-ascending-dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Healthy Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Sep 9, 2015

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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