A study to evaluate the pharmacokinetics of Tezepelumab after being delivered by an accessorized pre filled syringe or autoinjector compared with vial and syringe in healthy adult subjects - PATH-BRIDGE

Study identifier:D5180C00012

ClinicalTrials.gov identifier:NCT03989544

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open label, Randomized, Parallel group Study to Evaluate the Pharmacokinetics of Tezepelumab Administered Subcutaneously via Accessorized Pre filled Syringe (APFS) or Autoinjector (AI) Compared with Vial and Syringe in Healthy Adult Subjects (PATH-BRIDGE)

Medical condition

asthma

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

315

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 19 Jun 2019

Primary Completion Date: 30 Dec 2019

Study Completion Date: 30 Dec 2019

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2022 by AstraZeneca

Collaborators

Amgen

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Healthy male and/or female subjects aged 18 to 65 years (inclusive) at the Screening Visit, with suitable veins for repeated venipuncture.
3. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Day 1) and must not be lactating.
4. Females of childbearing potential who are sexually active must use a highly effective method of contraception from the Screening Visit and must agree to continue using such precautions for 16 weeks after the dose of Investigational Medicinal Product (IMP). Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
5. Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 90 kg inclusive.
6. Intact normal skin without potentially obscuring tattoos, scars, pigmentation or lesions on the skin area intended for injection (abdomen, thigh, upper arm).

Exclusion Criteria

1. History of any clinically significant disease or disorder.
2. History of anaphylactic reaction to biologic therapy.
3. Acute upper or lower respiratory infection requiring antibiotics or antiviral medications.
4. History of tuberculosis.
5. History of known immunodeficiency disorder, including a positive human immunodeficiency virus, or the subject is taking antiretroviral medications.
6. Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to the Screening Visit.
7. Current smokers or those who have smoked or used nicotine products including e-cigarettes within the 3 months prior to the Screening Visit.
8. History of cancer:
Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the Screening Visit.
Subjects who have had other malignancies including breast cancer are eligible provided that curative therapy was completed at least 5 years prior to the Screening Visit.
9. Subjects who have previously received tezepelumab.

Location

Research Site

Berlin, Germany, 14050

Arms	Assigned Interventions
Experimental: Tezepelumab via Vial-and-syringe Participants will be randomized to a single dose of tezepelumab via SC administration with Vial-and-syringe	Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection
Experimental: Tezepelumab via APFS Participants will be randomized to a single dose of tezepelumab via SC administration with APFS	Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection
Experimental: Tezepelumab via AI Participants will be randomized to a single dose of tezepelumab via SC administration with AI	Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Dr. Rainard Fuhr

PAREXEL

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Trial Results Summaries