A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers

NCT ID: NCT06304961

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-08
• Study Completion Date: 2024-09-09

Brief Summary

The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms.

Detailed Description

This is a phase I, randomised, open-label, single-dose, single-centre, parallel group study investigating the relative bioavailability of two dosage forms of tozorakimab (test dosage form and reference dosage form).

The study will comprise of:

1. A screening period of 28 days

2. A Treatment period of 1 day

3. Ambulatory visits on scheduled days

c. A final follow-up visit on Day 113 (Week 16)

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tozorakimab Dosage form A (Test)

Participants will receive a single dose of Tozorakimab Dosage form A via subcutaneous (SC) injection.

Group Type: EXPERIMENTAL

Tozorakimab

Intervention Type: BIOLOGICAL

Tozorakimab will be administered as a single SC dose on Day 1.

Tozorakimab Dosage form B (Reference)

Participants will receive a single dose of Tozorakimab Dosage form B via SC injection.

Group Type: EXPERIMENTAL

Tozorakimab

Intervention Type: BIOLOGICAL

Tozorakimab will be administered as a single SC dose on Day 1.

Interventions

Tozorakimab

Tozorakimab will be administered as a single SC dose on Day 1.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy male and female participants aged 18 to 55 years.
• All females must have a negative pregnancy test at the screening visit and on admission to the Clinical Unit.
• Females of childbearing potential must not be lactating and, if heterosexually active, must agree to use an approved method of highly effective contraception.
• Females of non-childbearing potential must be confirmed at the screening visit.
• Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
• Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 55 kg and no more than 100 kg inclusive.
• Intact normal skin without potentially obscuring tattoos, scars, etc, at the injection site.

Exclusion Criteria

• History of any clinically significant disease or disorder (including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator).
• Any clinically significant abnormal findings in vital signs at the screening visit and/or admission (Day -1) to the Clinical Unit, as judged by the investigator.
• Any clinically significant abnormalities on 12-lead ECG at the screening visit and/or admission (Day -1) to the Clinical Unit, as judged by the investigator.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 6 months prior to the screening visit, as judged by the investigator.
• Any clinically important illness, medical/surgical procedure, or trauma within 8 weeks of the screening visit, or any planned inpatient surgery or hospitalisation during the study period.
• Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to enrolment. Suspected malignancy or undefined neoplasms.
• Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
• Any laboratory values with the following deviations at the screening visit or on admission (Day -1) to the Clinical Unit.
• Any clinically significant abnormal findings in physical examination at screening and/or admission (Day -1), which, in the opinion of the investigator, may put the participant at risk because of their participation in the study or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
• History of known immunodeficiency disorder, including a positive test for Human immunodeficiency virus-1 (HIV-1) or HIV-2.
• History or treatment for hepatitis B or hepatitis C or any positive test result on screening for Hepatitis B surface antigen (HBsAg), anti- Hepatitis B core (HBc) antibodies, or anti-hepatitis C antibodies.
• Evidence of active or latent Tuberculosis (TB).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

D9180C00011

Identifier Type: -

Identifier Source: org_study_id