Status:
COMPLETED
Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Amgen
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 Singl...
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 assig...
Eligibility Criteria
Inclusion
- Male and female healthy Chinese subjects
- Age 18 to 45
- Body weight ≥ 40 kg
- Body mass index (BMI) between 19-24 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04362410
Start Date
May 18 2020
End Date
October 9 2020
Last Update
November 17 2020
Active Locations (1)
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1
Research Site
Nanchang, China, 330006