A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes
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Lead
MedImmune LLC
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes
