The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.
This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of MEDI9929 will be investigated. Primary object is to assess the safety and tolerability of single ascending subcutaneous (SC) doses of MEDI9929 in healthy male Japanese subjects. Secondary objectives are to characterize the pharmacokinetics (PK) of MEDI9929 in healthy male Japanese subjects and to evaluate the immunogenicity (IM) of MEDI9929 in healthy male Japanese subjects. Up to 24 healthy subjects aged 20 to 45 years will participate in a maximum of 3 cohorts. Eight subjects will participate in each cohort. Subjects will be randomized in a 3:1 ratio (active: placebo) and will receive a single dose of either MEDI9929 or placebo. Each subject will only participate in one cohort. The first cohort will receive Dose 1 MEDI9929 (n=6) or placebo (n=2), the second cohort will receive Dose 2 MEDI9929 (n=6) or placebo (n=2), and the third cohort will receive Dose 3 MEDI9929 (n=6) or placebo (n=2). Following a screening period of a maximum of 28 days, subjects will stay at the study facility for eight nights starting from the day before dosing (Day -1) to Day 8. The follow up period after the dosing will be 84 days (112 days for cohort 3). Subjects will receive a single dose of MEDI9929 or placebo subcutaneously on Day 1 and safety monitoring and serial collection of blood samples for PK evaluation will be followed throughout the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
64
Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA
Fukuoka, Hakata, Japan
Research Site
Fukuoka, Japan
Description of the Safety and tolerability profile of MEDI9929
To investigate the safety and tolerability (Adverse events, blood pressure and pulse, Electrocardiogram, Body temperature, respiratory rate, Haematology, Clinical Chemistry, Urinalysis, and physical examination) of MEDI9929 following administration of single ascending doses.
Time frame: 84 days for cohort 1/2, 112 days for cohort 3
Description of Pharmacokinetics profile for MEDI9929
To characterize the pharmacokinetics of MEDI9929 after single SC dose in healthy male Japanese subjects. Where possible, the following PK parameters will be determined: Apparent SC clearance \[CL/F\], apparent SC volume of distribution \[Vz/F\], maximum observed serum concentration, \[Cmax\], time at which maximum concentration is observed \[tmax\], area under the serum concentration time curve from time zero to infinity \[AUC0-inf\] and to last observation \[AUC(0-t)\], elimination half-life \[t½, z\]
Time frame: 84 days for cohort 1/2, 112 days for cohort 3
Description of Immunogenicity profile for MEDI9929
Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI9929 in blood.
Time frame: 84 days for cohort 1/2, 112 days for cohort 3
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