Who is eligible for clinical trial NCT07646548?

Participants must meet the protocol's inclusion criteria for Healthy Volunteers. The stated age range is 18 Years to 60 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07646548 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-20

Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants (NCT07646548)

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

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Sanofi

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).

Location: Clinical Pharmacology of Miami- Site Number : 8400001 — Hialeah, Florida

Age range: 18 Years to 60 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Clinical Pharmacology of Miami- Site Number : 8400001 — Hialeah, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗