Healthy Volunteers
Conditions
Brief summary
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.
Interventions
BIOLOGICALDupilumab coformulated with berahyaluronidase alfa
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
BIOLOGICALDupilumab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
This study is open-label. Participants, investigators, and study members have access to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab | From Day 1 to Day 85 (end of study) | Cmax: Maximum concentration observed in serum |
| PK parameter in serum: AUClast of dupilumab | 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
| Measure | Time frame |
|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs | From Day -1 to Day 85. |
| Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa | On Day 1, Day 43 and Day 85 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngel Lamas, MD
Clinical Pharmacology of Miami (CPMI)
Outcome results
None listed