This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
This is a randomized, open label, cross-over, two-period, pilot study in healthy adult subjects to evaluate the bioequivalence between formulation 2 and formulation 3 of MEDI0382 after a single subcutaneous (SC) dose. The study will be conducted at a single US center. Each subject will be randomized to receive a single 100 μg (or equimolar equivalent) SC dose of both formulation 2 and 3 of MEDI0382 on two different in-house periods separated by a washout period of 7 days. Formulation 3 of MEDI0382 has not been administered to humans previously. Subjects will receive the same absolute amount of MEDI0382, when dosed with either formulation 2 or formulation 3. Formulations of MEDI0382 will be administered via SC injection in the abdomen of subjects. Subjects will be in the study for a maximum of 59 days, which includes a screening period of up to 21 days. On Day 1, subjects will admitted to the clinic and will be randomized to receive formulation 2 and formulation 3 in one of two sequences; subjects randomized to sequence 1 will receive formulation 2 on Day 1 and formulation 3 on Day 10 and subjects randomized to sequence 2 will receive formulation 3 on Day 1 and formulation 2 on Day 10. On Day 3, subjects will be discharged from the clinic and a 7-day washout period will follow. Subjects will return to the clinic on Day 10 to receive the second dose of investigational product and will remain in-house for 3 days. After discharge on Day 12, subjects will return on Day 38 for the end of study visit. Blood samples for PK analyses of MEDI0382 concentrations will be taken predose and at 11 time points up to 48 hours after dosing (Days 3 and 12). Bedside plasma glucose levels will be monitored before meals and at bedtime during Days 1 and 10 and will be measured prior to breakfast on Days 2 and 11.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Sequence 1 Period 1 and Sequence 2 Period 2.
Sequence 1 Period 2 and Sequence 2 Period 1
Research Site
Dallas, Texas, United States
Area under the drug concentration curve
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382
Time frame: 48 hours
Maximum observed plasma concentration of MEDI0382
To evaluate bioequivalence between formulation 2 and formulation 3 of MEDI0382.
Time frame: 48 hours
Area under the plasma drug concentration versus time curve from zero to infinity and to last observation
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Time to maximum observed plasma drug concentration
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Terminal phase elimination half-life
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Apparent clearance
To compare the pharmacokinetic (PK) profiles of MEDI0382 formulation 2 versus formulation 3.
Time frame: 48 hours
Adverse Events
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
12 lead electrocardiogram including RR, PR, QRS, QT, and QTc intervals
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Anti-drug antibody titer
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Vital signs (temperature)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Anti-drug antibody incidence
To evaluate the immunogenicity of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Clinical laboratory assessments (hematology)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Vital signs (systolic and diastolic blood pressure)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3.
Time frame: 38 days
Vital signs (pulse rate and respiratory rate)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Clinical laboratory assessments (serum chemistry)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
Clinical laboratory assessments (urinalysis)
To evaluate the safety and tolerability of a single dose of MEDI0382 in formulation 2 and 3
Time frame: 38 days
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