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Healthy volunteers test dupilumab manufacturing change

NCT ID NCT05976386

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed Phase 1 study tested whether a new version of the drug dupilumab works the same in the body as the current version. 182 healthy adults aged 18-65 received a single injection of either the new or current product. The goal was to compare how the drug is absorbed, 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
Dupilumab (injection)

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

182 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2021

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 65 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 or female participants, between 18 and 65 years of age, inclusive. * Body weight between 65.0 and 95.0 kg, inclusive. * Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: * Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness. * 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. * Presence or history of drug or biologic hypersensitivity, or allergic disease diagnosed and treated by a physician (excluding seasonal allergy). * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). * Smoking regularly and unable to stop smoking during the inpatient portion of the study (occasional smoker can be enrolled). * If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breastfeeding. * Any biologics (antibody or its derivatives) given within 4 months before inclusion or within 5 half-lives (whichever takes longer). * Participation in any previous clinical trial of dupilumab. * Participation in any clinical research study evaluating another investigational drug or therapy in which the inclusion visit for the current study will be within 30 days of receiving the drug or 5 elimination half-lives (whichever is longer). * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to a patient'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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