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

NCT07646548 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: PKM20425U1111-1331-0702
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab

  Cmax: Maximum concentration observed in serum

  From Day 1 to Day 85 (end of study)

• PK parameter in serum: AUClast of dupilumab

  AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast

  From Day 1 to Day 85 (end of study)

Secondary Outcomes (2)

• Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs

  From Day -1 to Day 85.

• Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa

  On Day 1, Day 43 and Day 85

Study Arms (2)

Treatment A

EXPERIMENTAL

Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1

Biological: Dupilumab coformulated with berahyaluronidase alfa

Treatment B

EXPERIMENTAL

Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1

Biological: Dupilumab

Interventions

Dupilumab BIOLOGICAL

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

Also known as: SAR231893, Dupixent

Treatment B

Dupilumab coformulated with berahyaluronidase alfa BIOLOGICAL

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

Also known as: SAR231893, Dupixent

Treatment A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

MeSH Terms

Interventions

dupilumab

Study Officials

• Angel Lamas, MD

  Clinical Pharmacology of Miami (CPMI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label. Participants, investigators, and study members have access to treatment assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share