drugset / Trial / NCT07646548

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

NCT07646548

Phase 1 Recruiting 40 enrolled Sanofi Regeneron Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2026-06-11
Primary completion
2026-09-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Berahyaluronidase alfa Protein / enzyme biologic Subcutaneous
Subject Dupilumab Monoclonal antibody Subcutaneous

Indications

No indication recorded.