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NCT07646548

Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants

Active, Not Recruiting
PHASE1Ages 18–60InterventionalBasic science
Sanofi
~40 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Dupilumab coformulated with berahyaluronidase alfaDupilumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
Measured over From Day 1 to Day 85 (end of study)
+1 more outcome measured

Conditions

Healthy Volunteers

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Healthy Volunteers

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Angel Lamas, MD · PRINCIPAL_INVESTIGATOR · Clinical Pharmacology of Miami (CPMI)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pharmacokinetic (PK) parameter in serum: Cmax of dupilumabFrom Day 1 to Day 85 (end of study)

    Cmax: Maximum concentration observed in serum

  • PK parameter in serum: AUClast of dupilumabFrom Day 1 to Day 85 (end of study)

    AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast