Healthy volunteers test dupilumab shot with enzyme helper
NCT ID NCT07646548
First seen Jun 26, 2026 · Last updated Jul 22, 2026 · Updated 3 times
Summary
This early-stage study is testing whether adding an enzyme called berahyaluronidase alfa changes how the body processes dupilumab (Dupixent), a drug used for conditions like eczema and asthma. Forty healthy adults will receive a single injection of dupilumab either with or without the enzyme. The goal is simply to compare the drug levels and side effects between the two groups — there is no treatment benefit for participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dupilumab (Dupixent) with or without berahyaluronidase alfa
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
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- 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 60 years
- Sex
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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 and/or female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent. * Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination). * Body weight between 50.0 and 100.0 kg, inclusive. * BMI between 18.0 and 32.0 kg/m2 (inclusive). Exclusion Criteria: * Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological, 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. * Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP of ≥30 mmHg within 3 minutes when changing from supine to standing position. * Presence or history of drug hypersensitivity, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to any of the study interventions, or components thereof. * History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis). * Regular smoking of more than 5 cigarettes or equivalent in nicotine per week, unable to stop smoking during the study (occasional smoker can be enrolled). * Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). * If female, pregnancy (defined as positive urine pregnancy 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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Genom att skicka in godkänner du våra Användarvillkor
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
Hialeah, Florida, 33014, United States
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