This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo.
This is a Phase I, randomised, single-blind, placebo-controlled, single-centre study. This study comprises upto a total of 42 subjects. This study consists of two parts: A single dose part (Part A1 and Part A2) and a multiple dose part (Part B). Part A and Part B will comprise of the following: * Each subject will be involved in the study for up to 9 weeks if enrolled in Part A and up to 10 weeks if enrolled in Part B. * A screening period of maximum 28 days. * Treatment period: Part A: Study treatment Day 1; Part B: Study treatment Days 1 to 6 and a single inhaled dose on Day 7. * A safety follow-up call will be conducted 7 (± 1) days after elarekibep or placebo administration. * A safety follow-up visit will be conducted 30 (± 2) days after elarekibep or placebo administration in each cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Subjects will receive single or multiple inhaled doses A, B or C, or single IV dose D of elarekibep.
Subjects will receive single or multiple inhaled doses A, B or C.
Research Site
Harrow, United Kingdom
Incidence of Adverse events
The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.
Time frame: Up to Follow-up [Part A: 60 days, Part B: 67 days)
Collection of blood samples for the measurement of safety immunobiomarkers
The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.
Time frame: Part A: Screening (Day -28) to Day 3; Part B: Screening (Day -28 to -2) to Follow-up ([Day 37 ± 2)]
Maximum observed serum (peak) drug concentration [Cmax]
The Cmax of elarekibep after single and multiple inhaled or single IV doses in healthy Japanese subjects will be evaluated.
Time frame: Part A: Day 1 to Day 3, Part B: Day 1 to Day 9
Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast)
The AUClast of elarekibep after single and multiple inhaled or single IV doses in healthy Japanese subjects will be evaluated.
Time frame: Part A: Day 1 to Day 3, Part B: Day 1 to Day 9
Area under serum concentration time curve from zero to infinity (AUCinf)
The AUCinf of elarekibep after single and multiple inhaled or single IV doses in healthy Japanese subjects will be evaluated.
Time frame: Day 1
Presence of elarekibep Antidrug Antibody (ADA)
The immunogenicity of elarekibep in healthy Japanese subjects will be evaluated.
Time frame: Part A: Day 1; Part B: Day 1, Day 14 to Follow-up/ETV ([Day 37 ± 2)
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Standardised taste questionnaires
Taste characteristics will be assessed within 5 minutes from dosing. There are 10 questions each of which is scored on a scale of 0 to 10 where 0 is the low range while 10 is the extreme range. Palatability will be assessed as measured by taste scores.
Time frame: Part A: Day 1, Part B: Day 1