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NCT Number: NCT02524782

A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes

A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Anniston, Alabama, United States

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About this study

This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 Diabetes, ages 18-65
  • Must provide written informed consent
  • BMI>=25 and =<42
  • 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 basal cell carcinoma or carcinoma of the cervix
  • 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
  • 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 weight loss is prohibited.
  • Positive drug screen
  • Type 1 diabetes

Treatment and study plan

MEDI-4166

Biological

MEDI-4166 administered subcutaneously

Placebo

Biological

Placebo administered subcutaneously

Primary outcomes

  1. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 43 days post dosing

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

  2. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 43 days post dosing

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

  3. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 43 days post dosing

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

  4. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 43 days post dosing

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

  5. Part A: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 43 days post dosing

    Physical examination

  6. Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36

    Time frame: 36 days post dosing

    Part B: Change in glucose AUC measured up to 240 minutes after mixed meal tolerance test (MMTT) from baseline to Day 36

  7. Part B: Change in LDL-C from baseline to Day 36

    Time frame: 36 days post dosing

    Part B: Change in LDL-C from baseline to Day 36

Secondary outcomes

  1. Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

    Time frame: 43 days post dosing

    Part A: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

  2. Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

    Time frame: 43 days post dosing

    Part A: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

  3. Part A: Change from baseline in LDL-C

    Time frame: 43 days post dosing

    Part A: Change from baseline in LDL-C

  4. Part A: Proportion of subjects with Anti-drug Antibodies (ADA) to MEDI4166

    Time frame: 43 days post dosing

    Part A: Proportion of subjects with ADA to MEDI4166

  5. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 71 days post dosing

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

  6. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 71 days post dosing

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

  7. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 71 days post dosing

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

  8. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 71 days post dosing

    Clinical laboratory assessments (serum chemistry, hematology, urinalysis)

  9. Part B: Number of subjects with adverse events as a measure of safety and tolerability of MEDI4166

    Time frame: 71 days post dosing

    Physical examination

  10. Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

    Time frame: 71 days post dosing

    Part B: Pharmacokinetics of MEDI4166, maximum plasma concentration (Cmax)

  11. Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

    Time frame: 71 days post dosing

    Part B: Pharmacokinetics of MEDI4166, area under the curve concentration (AUC)

  12. Part B: Change from baseline in fructosamine levels

    Time frame: 36 days post dosing

    Part B: Change from baseline in fructosamine levels

  13. Part B: Proportion of subjects with ADA to MEDI4166

    Time frame: 71 days post dosing

    Part B: Proportion of subjects with ADA to MEDI4166

  14. Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

    Time frame: 43 days post dosing

    Part A: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

  15. Part A: Change from baseline in glucose AUC up to 240 minutes

    Time frame: 43 days post dosing

    Part A: Change from baseline in glucose AUC up to 240 minutes

  16. Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

    Time frame: 71 days post dosing

    Part B: Pharmacokinetics of MEDI4166, time to maximum observed plasma drug concentration (Tmax)

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1, Combined Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of MEDI4166 in Subjects With Type 2 Diabetes Mellitus (T2D)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2015
Registry last updated
Mar 13, 2019

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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