Healthy ParticipantsPhase 1NCT06304961
A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers
A Phase 1 study testing Tozorakimab in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Tozorakimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 8 Apr 2024to 9 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- A screening period of 28 days
- A Treatment period of 1 day
- Ambulatory visits on scheduled days
- A final follow-up visit on Day 113 (Week 16)
- Conditions
- Healthy Participants
- Being tested
- Tozorakimab
- Keywords
- Human immunoglobulin G1 monoclonal antibody, Chronic Obstructive Pulmonary Disease, Asthma, Pharmacokinetics, Bioavailability
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TozorakimabBiological
Tozorakimab will be administered as a single SC dose on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Tozorakimab Dosage form A (Test) | Experimental | Participants will receive a single dose of Tozorakimab Dosage form A via subcutaneous (SC) injection. Receives: Biological: Tozorakimab |
| Tozorakimab Dosage form B (Reference) | Experimental | Participants will receive a single dose of Tozorakimab Dosage form B via SC injection. Receives: Biological: Tozorakimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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)
To examine the tmax of two different dosage forms of tozorakimab (test and reference).
Measured: 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)
To examine the t1/2 of two different dosage forms of tozorakimab (test and reference).
Measured: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Terminal rate constant (λz)
To examine the λz of of two different dosage forms of tozorakimab (test and reference).
Measured: 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)
To examine the CL/F of two different dosage forms of tozorakimab (test and reference).
Measured: 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)
To examine the Vz/F of two different dosage forms of tozorakimab (test and reference).
Measured: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
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.
Measured: From screening (Day -28) to last follow-up visit (Day 113- approximately 21 weeks).
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.
Measured: Day 1 (Pre-dose), Days 29, 57 and 113 (Post-dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start8 Apr 2024
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304961
- Sponsor's protocol ID
- D9180C00011
- Status last verified
- Sep 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06304961
- Acronym / sponsor ID
- D9180C00011
- Conditions
- Healthy Participants
- Keywords
- Human immunoglobulin G1 monoclonal antibody, Chronic Obstructive Pulmonary Disease, Asthma, Pharmacokinetics, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A screening period of 28 days
- A Treatment period of 1 day
- Ambulatory visits on scheduled days
- A final follow-up visit on Day 113 (Week 16)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tozorakimab Dosage form A (Test) | Experimental | Biological: TozorakimabParticipants will receive a single dose of Tozorakimab Dosage form A via subcutaneous (SC) injection. |
| Tozorakimab Dosage form B (Reference) | Experimental | Biological: TozorakimabParticipants will receive a single dose of Tozorakimab Dosage form B via SC injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TozorakimabTozorakimab will be administered as a single SC dose on Day 1. | Biological | Tozorakimab Dosage form A (Test), Tozorakimab Dosage form B (Reference) |
Primary outcome
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).
Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).
Maximum observed drug concentration (Cmax)
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference).
7 secondary outcomes
Time to reach peak or maximum observed concentration following tozorakimab administration (tmax)
Time frame: 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)
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Terminal rate constant (λz)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
Number of participants with adverse events (AEs)
Time frame: From screening (Day -28) to last follow-up visit (Day 113- approximately 21 weeks).
Number of participants with presence of Anti-Drug Anitbodies (ADAs)
Time frame: Day 1 (Pre-dose), Days 29, 57 and 113 (Post-dose).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tozorakimab in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time 0 to infinity (AUCinf) (time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.