Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) for Cohorts 1, 2, and 3 |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is 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. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively) |
|
Primary |
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs for Cohorts 1, 2, and 3 |
Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters were defined as any abnormal finding during analysis of hematology, clinical chemistry, and urinalysis. |
From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively) |
|
Primary |
Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs for Cohorts 1, 2, and 3 |
Number of participants with abnormal vital signs (body temperature, blood pressure, heart rate, and respiratory rate) and physical examinations reported as TEAEs are reported. |
From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively) |
|
Primary |
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs for Cohorts 1, 2, and 3 |
Number of participants with abnormal ECG parameters reported as TEAEs are reported. |
From Day 1 through 28 days after the last dose of study drug (approximately 13, 18, and 22 weeks for Cohorts 1, 2, and 3, respectively) |
|
Primary |
Change in Blood Pressure from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 |
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in blood pressure from baseline to end of dosing measured by telemetry for Cohort 1 are reported. |
From Baseline (Day -1) through end of dosing (Day 63) |
|
Primary |
Change in Respiratory Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 |
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in respiratory rate from baseline to end of dosing measured by telemetry for Cohort 1 are reported. |
From Baseline (Day -1) through end of dosing (Day 63) |
|
Primary |
Change in Pulse Rate from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 |
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in pulse rate from baseline to end of dosing measured by telemetry for Cohort 1 are reported. |
From Baseline (Day -1) through end of dosing (Day 63) |
|
Primary |
Change in Temperature from Baseline to End of Dosing as Measured by Telemetry for Cohort 1 |
Telemetry is the process of recording and transmitting the vital readings (temperature, blood pressure, pulse rate, and respiratory rate). It is used to continuously monitor vital reading as a real-time safety measure. Mean change in temperature from baseline to end of dosing measured by telemetry for Cohort 1 are reported. |
From Baseline (Day -1) through end of dosing ( Day 63) |
|
Secondary |
Maximum Observed Plasma Concentration (Cmax) of MEDI0382 for Cohort 1 |
The Cmax of MEDI0382 (Cotadutide) for MEDI0382 Doses 1 to 7 for Cohort 1 are reported. |
Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively |
|
Secondary |
Cmax of MEDI0382 Dose 1 on Day 1 for Cohort 1 |
The Cmax of MEDI0382 Dose 1 for Cohort 1 is reported. |
Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 |
|
Secondary |
Area Under the Concentration-time Curve at the end of the Dosing interval (AUCt) of MEDI0382 for Cohort 1 |
The AUCt of MEDI0382 for MEDI0382 Doses 1 to 7 for Cohort 1 are reported. |
Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively |
|
Secondary |
AUCt of MEDI0382 Dose 1 on Day 1 for Cohort 1 |
The AUCt of MEDI0382 Dose 1 for Cohort 1 is reported. |
Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 |
|
Secondary |
Time to Maximum Observed Plasma Concentration (Tmax) of MEDI0382 for Cohort 1 |
The Tmax of MEDI0382 for MEDI0382 Doses 1 to 7 for Cohort 1 are reported. |
Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Days 7, 14, 21, 28, 35, 42, and 49 for MEDI0382 Doses 1 to 7, respectively |
|
Secondary |
Tmax of MEDI0382 Dose 1 on Day 1 for Cohort 1 |
The Tmax of MEDI0382 Dose 1 for Cohort 1 is reported. |
Predose (-5 minutes) and 1, 2, 4, 6, 8, 12, and 24 hours postdose on Day 1 |
|
Secondary |
Plasma Concentration of MEDI0382 for Cohorts 2 and 3 |
Plasma concentration of MEDI0382 for predose and 6 hours postdose for Cohorts 2 and 3 are reported. |
Cohort 2: predose and 6 hours postdose on Days 1, 15, 29, 43, and 57 for MEDI0382 Doses 1, 2, 3, 5, and 7, respectively; Cohort 3: predose and 6 hours postdose on Days 1, 29, 57, and 85 for MEDI0382 Doses 1, 8, 4, and 7, respectively |
|
Secondary |
Plasma Concentration of MEDI0382 Dose 7 on Day 71 for Cohort 2 and MEDI0382 Dose 7 on Day 113 for Cohort 3 |
Plasma concentration of MEDI0382 Dose 7 for predose and 6 hours postdose on Day 71 for Cohort 2 and on Day 113 for Cohort 3 are reported. |
Cohort 2: predose and 6 hours postdose on Day 71 for MEDI0382 Dose 7; Cohort 3: predose and 6 hours postdose on Day 113 for MEDI0382 Dose 7 |
|
Secondary |
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI0382 in all Cohorts |
Number of participants with positive ADA to MEDI0382 are reported. |
Predose on Baseline (Day -1) and follow-up visit (28 days after the last dose) for each cohort; predose on Days 28 and 50 for Cohort 1, on Days 7, 28, 71, 98 for Cohort 2, and on Days 7, 28, 71, 126 for Cohort 3 |
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