Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects (DIRECTION-CK)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Other: Placebo; Biological: Experimental: Tezepelumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04362410

D5180C00020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Tezepelumab: Low dose

Experimental group

Description:

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Treatment:

Biological: Experimental: Tezepelumab

Tezepelumab: Medium dose

Experimental group

Description:

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Treatment:

Biological: Experimental: Tezepelumab

Tezepelumab: High dose

Experimental group

Description:

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Treatment:

Biological: Experimental: Tezepelumab

Placebo

Placebo Comparator group

Description:

Placebo single dose subcutaneously injection.

Treatment:

Other: Placebo