A Phase 1 interventional study of Experimental: Tezepelumab and Placebo in Healthy Subjects, sponsored by AstraZeneca. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
This is a Phase 1, Single Centre, Double-blind, Randomized, Placebo-controlled Parallel-group Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Tezepelumab after Single-Dose Subcutaneous Administration in Healthy Chinese Subjects.
This is a Phase 1, single centre, randomized, double-blind, placebo-controlled, single dose, parallel group study in healthy Chinese male or female subjects. 48 healthy subjects will be randomly assigned to one of the three treatment cohorts (i.e. 1:1:1 to Low dose, Medium dose and High dose) to receive a single dose of tezepelumab or placebo in a 3:1 ratio. Each subject will only participate in one cohort. Dose level is unblinded and treatment (tezepelumab or placebo) will be double-blinded within each treatment cohort. Following a screening period of a maximum of 28 days, subjects will stay at the study facility for two nights starting from the day before dosing (Day -1) to Day 2. Subjects will receive a single dose of tezepelumab 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. The follow up period after the dosing will be 112 days.
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Exclusion Criteria:
Tezepelumab: Tezepelumab single dose subcutaneously injection.
Biological: Experimental: Tezepelumab
Tezepelumab: Tezepelumab single dose subcutaneously injection.
Biological: Experimental: Tezepelumab
Tezepelumab: Tezepelumab single dose subcutaneously injection.
Biological: Experimental: Tezepelumab
Placebo single dose subcutaneously injection.
Other: Placebo
Tezepelumab single dose subcutaneously injection.
Also known as: Tezepelumab
Placebo single dose subcutaneously injection.
AUC0-inf (Area under the serum concentration versus time curve from time zero to Infinity)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
AUC0-t (Area under the serum concentration versus time curve from time zero to the last quantifiable concentration)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
Cmax (Maximum serum concentration)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
tmax (time to Cmax)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
t1/2 (terminal serum half-life)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
CL/F (apparent serum clearance)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
Vz/F (apparent volume of distribution)
To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects
Time frame: Blood samples will be collected from Day 1 (3 hour prior to administration of IP) and on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85 and Day 113.
Immunogenicity anti-drug antibodies
Incidence of anti-drug antibodies following single dose of tezepelumab
Time frame: Blood samples will be collected on Day 1 (3 hour prior to administration of IP) and on Day 29, Day 113.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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