MedDataX Logo

Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects

NCT ID: NCT04362410

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-10-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pharmacokinetics Safety Tolerability Immunogenicity Tezepelumab Healthy Chinese Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
double-blinded

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tezepelumab: Low dose

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Group Type EXPERIMENTAL

Experimental: Tezepelumab

Intervention Type BIOLOGICAL

Tezepelumab single dose subcutaneously injection.

Tezepelumab: Medium dose

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Group Type EXPERIMENTAL

Experimental: Tezepelumab

Intervention Type BIOLOGICAL

Tezepelumab single dose subcutaneously injection.

Tezepelumab: High dose

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Group Type EXPERIMENTAL

Experimental: Tezepelumab

Intervention Type BIOLOGICAL

Tezepelumab single dose subcutaneously injection.

Placebo

Placebo single dose subcutaneously injection.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo single dose subcutaneously injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Experimental: Tezepelumab

Tezepelumab single dose subcutaneously injection.

Intervention Type BIOLOGICAL

Placebo

Placebo single dose subcutaneously injection.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tezepelumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jinfang Hu, Master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Nanchang, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D5180C00020

Identifier Type: -

Identifier Source: org_study_id