Trials Sponsors Conditions Drugs Pricing

Conditions

healthy volunteers Healthy Participants

Keywords

Human immunoglobulin G1 monoclonal antibodyChronic Obstructive Pulmonary DiseaseAsthmaPharmacokineticsBioavailability

Outcome Measures

Primary Outcomes (3)

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).
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).
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 Outcomes (7)

Time to reach peak or maximum observed concentration following tozorakimab administration (tmax)
Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Terminal elimination half-life (t1/2)
Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Terminal rate constant (λz)
Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Apparent total body clearance (CL/F)
Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Apparent volume of distribution based on the terminal phase (Vz/F)
Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
+2 more secondary outcomes

Study Arms (2)

Tozorakimab Dosage form A (Test)

EXPERIMENTAL

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

Biological: Tozorakimab

Tozorakimab Dosage form B (Reference)

EXPERIMENTAL

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

Biological: Tozorakimab

Interventions

TozorakimabBiological

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

Tozorakimab Dosage form A (Test)Tozorakimab Dosage form B (Reference)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

AstraZeneca AB
Industrylead
AstraZeneca
Industrylead

Study Sites (1)

Research Site

Berlin, 14050, Germany

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Enrollment

46 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

April 8, 2024

Actual (reported)

Primary Completion

You may not qualify if:

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).

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (2)

Tozorakimab Dosage form A (Test)

Tozorakimab Dosage form B (Reference)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (7)

Study Arms (2)

Tozorakimab Dosage form A (Test)

Tozorakimab Dosage form B (Reference)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations