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

Part of paid clinical trials in Hialeah, Florida.

Sponsor
Sanofi
Study ID
NCT07646548
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 11, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Treatment A
    Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1
  • Experimental: Treatment B
    Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1

Primary Outcome Measure

Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab [ Time Frame: From Day 1 to Day 85 (end of study) ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami- Site Number : 8400001HialeahFlorida33014-

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Clinical Pharmacology of Miami· Hialeah, FL

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