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Active, Not Recruiting

NCT Number: NCT07646548

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

This is a Phase 1 study with 2 parallel groups of healthy participants. Participants will be randomized to receive either a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa or a SC dose of dupilumab without berahyaluronidase alfa.

The purpose of this study is to assess the pharmacokinetic (PK) characteristics of a single SC dose of dupilumab coformulated with berahyaluronidase alfa and dupilumab without berahyaluronidase alfa in healthy participants aged ≥18 and ≤60 years.

Study details include:

* The study duration will be approximately up to 12 to 15 weeks. * The treatment will be administered as a single dose on Day 1. * The number of visits will be 14.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami- Site Number : 8400001

Hialeah, Florida, 33014, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab coformulated with berahyaluronidase alfa

Biological

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Other names: SAR231893, Dupixent

dupilumab

Biological

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection

Other names: SAR231893, Dupixent

Primary outcomes

  1. Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab

    Time frame: From Day 1 to Day 85 (end of study)

    Cmax: Maximum concentration observed in serum

  2. PK parameter in serum: AUClast of dupilumab

    Time frame: From 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

Secondary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs

    Time frame: From Day -1 to Day 85.

  2. Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa

    Time frame: On Day 1, Day 43 and Day 85

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

Phase 1, Single Center, Open-label, Randomized, Parallel-group Study to Evaluate Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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