This study will evaluate safety, tolerability, pharmacokinetics and immunogenicity of MEDI7352 in healthy participants.
The study will comprise: * A Screening Period of up to 36 days (approximately 5 weeks); * A Treatment Period of 6 weeks where participants will be given 1 dose of study treatment every 2 weeks (4 doses in total). Participants will be required to stay in the Clinical Unit from Days -1 to 8 (Visit 2), from Days 14 to 15 (Visit 6), from Days 28 to 29 (Visit 9), and from Days 42 to 50 (Visit 12). In addition, participants will have multiple visits to the Clinical Unit to complete the study assessments; * A Follow-up Period of 42 days (6 weeks) where participants will also have multiple visits to the Clinical Unit to complete the study assessments, and; * A final Follow-up Visit after 42 days after the Treatment Period. Participants will receive fixed multiple subcutaneous (SC) doses of MEDI7352 or placebo on 4 occasions; one dose every 2 weeks on Days 1, 15, 29 and 43, under fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions.
Matching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions.
Research Site
Harrow, United Kingdom
Number of participants with adverse events (AEs)
To evaluate the safety and tolerability of MEDI7352 in healthy Japanese and Caucasian participants following multiple dosing by the SC route
Time frame: Upto Final Follow-up (Day 84) or Early Termination
Maximum concentration (Cmax) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to pharmacokinetic (PK) following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Time of Cmax (tmax) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve from time 0 to infinity (AUCinf) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve from time 0 to the time of the last quantifiable serum concentration (AUClast) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
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Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Area under the serum concentration-time curve for the dosing interval (AUCτ) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Average drug concentration over a dosing interval (Cavg) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Apparent volume of distribution at steady state (Vss/F) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Half-life (t1/2) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Apparent total body clearance (CL/F) for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to PK following multiple dosing by the SC route.
Time frame: 1st dose: pre-dose (Day 1), post-dose Day 2, 4, 6, 8, 10 and 12; 2nd and 3rd doses: pre-dose (Days 15 and 29) and 7 days post-dose (Days 22 and 36); 4th dose: pre-dose (Day 43), post-dose Days 44, 46, 48, 50, 52, 54, 57, 64, 71
Number of participants with positive/negative antidrug antibodies (ADA) result for MEDI7352
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to immunogenicity following multiple dosing by the SC route.
Time frame: Days 1, 15, 29 and 43 and at Follow-up Visit (Days 50, 64, and 84)
ADA titers testing for all ADA-positive samples as measure of immunogenicity
To further assess MEDI7352 in healthy Japanese and Caucasian participants with respect to immunogenicity following multiple dosing by the SC route.
Time frame: Days 1, 15, 29 and 43 and at Follow-up Visit (Days 50, 64, and 84)