Healthy volunteers help test injection devices for new drug

NCT ID NCT06908577

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested whether the drug tozorakimab enters the body the same way when given by two different injection devices: an autoinjector and a prefilled syringe. 254 healthy adults each received one injection. The goal was to see if the devices deliver the drug consistently, which helps with future use. No treatment was given for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

254 people

The number who actually took part.

Started

Apr 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy adults with suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the screening visit and on admission. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, in order to avoid pregnancy from the time of administration of study intervention until 16 weeks after administration of the study intervention (Day 113). * 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 from the time of administration of the study intervention until 16 weeks after administration of the study intervention (Day 113). * 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 at screening and Day -1. * Intact normal skin without potentially obscuring tattoos, scars, etc., at the injection site. Exclusion Criteria: * History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results of the study or the participant's ability to participate in the study. * Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalization during the study period. * Malignancy, current or within the past 5 years, suspected malignancy or undefined neoplasms. * Any abnormal laboratory values and vital signs. * History of known immunodeficiency disorder, including a positive test for human immunodeficiency virus (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 currently active tuberculosis (TB) disease or use of any TB drug treatment in the past 12 months or latent TB infection. * Any clinically significant abnormalities on 12lead electrocardiogram (ECG) at the screening visit and/or admission (Day -1) to the Clinical Unit. * History of or ongoing severe clinically important allergy/hypersensitivity, or history of hypersensitivity to monoclonal or polyclonal antibodies. History of allergy or reaction to any formulation components of the investigational medicinal product (IMP). * Receipt of live attenuated vaccines within 30 days prior to randomization and receipt of COVID-19 or inactivated vaccines within 14 days prior to randomization. * Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months or 5 half-lives of time of dosing in this study, whichever is longer. * Receipt of any investigational biologic within 4 months or 5 half-lives prior to the date of dosing in this study, whichever is longer.

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Conditions

The condition(s) this trial relates to.

Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Research Site

    Glendale, California, 91206, United States

  • Research Site

    Baltimore, Maryland, 21225, United States

  • Research Site

    Berlin, 14050, Germany

  • Research Site

    Harrow, HA1 3UJ, United Kingdom

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