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Healthy volunteers help compare two injection devices for amlitelimab

NCT ID NCT07146750

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tested two different injection devices for delivering the drug amlitelimab under the skin. It involved 212 healthy adults aged 18 to 55. The goal was to see if the devices deliver the same amount of drug and are safe, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amlitelimab

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

212 people

The number who actually took part.

Started

Aug 2025

Finished

Apr 2026

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: * Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF). * Certified as healthy by a comprehensive clinical assessment \[detailed medical history and complete physical examination including neurological exam (at screening and D1), skin, and mucous membranes\]. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg/m2, inclusive. Exclusion Criteria: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * Known history of significant immunosuppression or suspected current significant immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and cured for more than 5 years prior to baseline). * History of solid organ (including corneal transplant) or stem cell transplant. * Any pre-planned major elective surgery known about at baseline visit that in the Investigator's opinion would impede participation in the study. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month). * Blood donation, any volume, within 2 months before inclusion. * Any nicotine use within 4 weeks before study inclusion. Regular smoking more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking or using nicotine for duration of the study. * If female, pregnancy (defined as positive beta human chorionic gonadotropin \[β-HCG\] blood test), breast feeding. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Clinical Pharmacology of Miami- Site Number : 8400001

    Miami, Florida, 33014, United States

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