Healthy Subjects
Conditions
Keywords
Pharmacokinetics, Safety, Tolerability, Immunogenicity, Tezepelumab, Healthy Chinese Subjects
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALExperimental: Tezepelumab
Tezepelumab single dose subcutaneously injection.
OTHERPlacebo
Placebo single dose subcutaneously injection.
Sponsors
Amgen
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blinded
Intervention model description
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). 16 subjects will participate in each treatment cohort. Within each cohort, subjects will be randomized in a 3:1 ratio to receive a single dose of tezepelumab or placebo. Each subject will only participate in one cohort.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female healthy Chinese subjects * Age 18 to 45 * Body weight ≥ 40 kg * Body mass index (BMI) between 19-24 kg/m2
Exclusion criteria
* History or evidence of a clinically significant disorder * History of cancer * Smokers of \> 5 cigarettes/day * Receipt of any marketed or investigational biologic within 4 months or 5 half-lives/non-biologic agent within 30 days or 5 half-lives prior to randomization * History of chronic alcohol or drug abuse * Hepatitis B, C or HIV * Pregnant or breastfeeding * History of anaphylaxis following any biologic therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vz/F (apparent volume of distribution) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
| AUC0-inf (Area under the serum concentration versus time curve from time zero to Infinity) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
| AUC0-t (Area under the serum concentration versus time curve from time zero to the last quantifiable concentration) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
| Cmax (Maximum serum concentration) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
| tmax (time to Cmax) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
| t1/2 (terminal serum half-life) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
| CL/F (apparent serum clearance) | 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. | To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity anti-drug antibodies | Blood samples will be collected on Day 1 (3 hour prior to administration of IP) and on Day 29, Day 113. | Incidence of anti-drug antibodies following single dose of tezepelumab |
Countries
China
Outcome results
None listed