Healthy volunteers test dupilumab manufacturing change
NCT ID NCT05976386
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 Hide 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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