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.
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).
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.
Parallel
Dupilumab coformulated with berahyaluronidase alfa
Biological/VaccinePharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Dupilumab
Biological/VaccinePharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
Cmax: Maximum concentration observed in serum
PK parameter in serum: AUClast of dupilumab
AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs
Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa
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Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
