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
Sanofi
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- 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, arti…
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
Location
- Clinical Pharmacology of Miami- Site Number : 8400001Hialeah, Florida