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RECRUITING
NCT07646548
PHASE1

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-06-11

Completion Date

2026-09-30

Last Updated

2026-06-24

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Dupilumab coformulated with berahyaluronidase alfa

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

BIOLOGICAL

Dupilumab

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

Locations (1)

Clinical Pharmacology of Miami- Site Number : 8400001

Hialeah, Florida, United States