Tozorakimab for Healthy Subjects

Not currently recruiting at 3 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: TB drugs, Live vaccines

Disqualifiers: Malignancy, Immunodeficiency, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tozorakimab in healthy individuals. The goal is to observe how the body absorbs this treatment when administered through two different devices. Participants will receive a single dose of tozorakimab via either an AI device or an APFS device. Ideal participants are healthy adults with good vein access for blood samples. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that you may need to avoid certain medications. Please consult with the study coordinators for specific guidance.

What prior data suggests that this device is safe for healthy subjects?

Research shows that tozorakimab has been tested in healthy people before. In these studies, participants tolerated tozorakimab well, with no major side effects. One study found no safety concerns among healthy participants who received the treatment. This suggests that tozorakimab is generally safe for humans, based on data from previous testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tozorakimab because it offers a unique delivery method compared to standard treatments. Unlike typical medications that might require more frequent dosing or different administration methods, tozorakimab is delivered as a single subcutaneous dose using advanced devices. This trial is particularly interesting because it compares two different delivery devices: the AI device and the APFS device. Both aim to optimize how the drug is administered, potentially improving patient experience and adherence.

What evidence suggests that tozorakimab is effective for healthy subjects?

Research shows that tozorakimab, a type of medication, may help treat certain conditions by reducing inflammation. Early studies have shown positive results in some patient groups, suggesting it might outperform a placebo. Although the main goals of some studies weren't achieved for everyone, these early findings remain promising. Additionally, trials have shown that tozorakimab is well tolerated, with no major safety issues identified. This trial will compare two different methods of administering tozorakimab to healthy subjects, potentially offering further insights into its potential for treating inflammation-related conditions. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults with good veins for blood draws, a BMI between 19 and 30 kg/m2, and weight between 55-100 kg. Women must not be pregnant or breastfeeding and use contraception if of childbearing potential. Men with partners who can bear children must also use contraception.

Inclusion Criteria

I am not pregnant, as confirmed by tests.

I am not able to have children, as confirmed during screening.

I have veins suitable for repeated needle insertions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single subcutaneous dose of tozorakimab using either an AI or APFS device

9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

85 days

Final Follow-up Visit

A final follow-up visit to assess long-term safety and PK parameters

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tozorakimab

Trial Overview The study aims to compare how the body absorbs Tozorakimab when given by an autoinjector (AI) versus an accessorised prefilled syringe (APFS). Participants will receive a single subcutaneous dose using one of these devices.

How Is the Trial Designed?

Group I: Treatment A: Tozorakimab (Test) Experimental Treatment 2 Interventions

Participants will receive a single SC dose of tozorakimab via AI device.

Group II: Treatment B: Tozorakimab (Reference) Active Control 2 Interventions

Participants will receive a single SC dose of tozorakimab via APFS device with the same container closure as the AI.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12256803/

A phase 2a trial of the IL-33 monoclonal antibody ... Although the primary end-point was not met in the intent-to-treat population, tozorakimab showed positive efficacy signals versus placebo in a subgroup of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05166889

NCT05166889 | Efficacy and Safety of Tozorakimab in ... The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult ...

3. nature.com nature.com/articles/s41598-023-36642-y

Tozorakimab (MEDI3506): an anti-IL-33 antibody that ... Tozorakimab is a novel therapeutic agent with a dual mechanism of action that blocks IL-33 red and IL-33 ox signalling, offering potential to reduce ...

4. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3147

A Randomized Phase I Study of the Anti‐Interleukin‐33 ... The results from this study showed that tozorakimab was well tolerated with no safety concerns identified. No dose–response effects in the ...

5. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D9180C00003

Efficacy and Safety of Tozorakimab in Symptomatic ... The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38115209/

A Randomized Phase I Study of the Anti-Interleukin-33 ... In part 3, 8 healthy Japanese participants received a single intravenous dose of tozorakimab or placebo. The safety data collected included treatment ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05742802

Study Details | NCT05742802 | Long-term Efficacy and ... Phase 3, extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and ...