Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects

Healthy Subjects Clinical Trial

— DIRECTION-CK  

Official title:

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 (DIRECTION-CK)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362410
• Other study ID #: D5180C00020
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2020
• Est. completion date: October 9, 2020

Study information

• Verified date: November 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 9, 2020
• Est. primary completion date: October 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• Experimental: Tezepelumab
Tezepelumab single dose subcutaneously injection.

Other:
• Placebo
Placebo single dose subcutaneously injection.

Locations

Country	Name	City	State
China	Research Site	Nanchang

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Amgen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Primary	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	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.
Primary	Cmax (Maximum serum concentration)	To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects	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.
Primary	tmax (time to Cmax)	To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects	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.
Primary	t1/2 (terminal serum half-life)	To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects	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.
Primary	CL/F (apparent serum clearance)	To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects	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.
Primary	Vz/F (apparent volume of distribution)	To investigate the pharmacokinetics of single subcutaneous dose of tezepelumab in healthy Chinese subjects	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.
Secondary	Immunogenicity anti-drug antibodies	Incidence of anti-drug antibodies following single dose of tezepelumab	Blood samples will be collected on Day 1 (3 hour prior to administration of IP) and on Day 29, Day 113.