Tezepelumab Phase 1 PK Study in Healthy Chinese Subjects

NCT04362410 | Completed Phase 1 FDA Drug

• 1 other identifier: D5180C00020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Pharmacokinetics; Safety; Tolerability; Immunogenicity; Tezepelumab; Healthy Chinese Subjects

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• 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.

Study Arms (4)

Tezepelumab: Low dose

EXPERIMENTAL

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Biological: Experimental: Tezepelumab

Tezepelumab: Medium dose

EXPERIMENTAL

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Biological: Experimental: Tezepelumab

Tezepelumab: High dose

EXPERIMENTAL

Tezepelumab: Tezepelumab single dose subcutaneously injection.

Biological: Experimental: Tezepelumab

Placebo

PLACEBO COMPARATOR

Placebo single dose subcutaneously injection.

Other: Placebo

Interventions

Experimental: Tezepelumab BIOLOGICAL

Tezepelumab single dose subcutaneously injection.

Also known as: Tezepelumab

Tezepelumab: High dose; Tezepelumab: Low dose; Tezepelumab: Medium dose

Placebo OTHER

Placebo single dose subcutaneously injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female healthy Chinese subjects
• Age 18 to 45
• Body weight ≥ 40 kg
• Body mass index (BMI) between 19-24 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Amgen: collaborator

Study Sites (1)

Research Site

Nanchang, 330006, China

Location

MeSH Terms

Interventions

tezepelumab

Study Officials

• Jinfang Hu, Master

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 24, 2020
• Study Start: May 18, 2020
• Primary Completion: October 9, 2020
• Study Completion: October 9, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

CN (1)