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

Healthy Participants Clinical Trial

Official title:

A Randomised, Single-dose, Parallel Group Study in Healthy Volunteers to Assess the Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06304961
• Other study ID #: D9180C00011
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 8, 2024
• Est. completion date: September 6, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: September 6, 2024
• Est. primary completion date: September 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve from time 0 to infinity (AUCinf)	To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Primary	Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast)	To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Primary	Maximum observed drug concentration (Cmax)	To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Secondary	Time to reach peak or maximum observed concentration following tozorakimab administration (tmax)	To examine the tmax of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Secondary	Terminal elimination half-life (t1/2)	To examine the t1/2 of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Secondary	Terminal rate constant (?z)	To examine the ?z of of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Secondary	Apparent total body clearance (CL/F)	To examine the CL/F of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Secondary	Apparent volume of distribution based on the terminal phase (Vz/F)	To examine the Vz/F of two different dosage forms of tozorakimab (test and reference).	Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Secondary	Number of participants with adverse events (AEs)	To assess the safety and tolerability of a single dose of tozorakimab administered subcutaneously via two different dosage forms in healthy participants.	From screening (Day -28) to last follow-up visit (Day 113- approximately 21 weeks).
Secondary	Number of participants with presence of Anti-Drug Anitbodies (ADAs)	To evaluate the immunogenicity of a single dose of tozorakimab administered subcutaneously via two different dosage forms in healthy participants.	Day 1 (Pre-dose), Days 29, 57 and 113 (Post-dose).