Active, not recruitingNCT07646548Updated Jul 21, 2026

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

A Phase 1 interventional study of Dupilumab coformulated with berahyaluronidase alfa and Dupilumab in Healthy Volunteers, sponsored by Sanofi. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Sanofi · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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 studied

Healthy Volunteers

In context

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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).

Exclusion criteria

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 40 participants (estimated)

Study arms

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

Interventions

BiologicalDupilumab coformulated with berahyaluronidase alfa
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Also known as: SAR231893, Dupixent
BiologicalDupilumab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Also known as: SAR231893, Dupixent

What researchers measure

Primary outcomes

Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
Cmax: Maximum concentration observed in serum
Time frame: 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
Time frame: From Day 1 to Day 85 (end of study)

Secondary outcomes

Number of participants with treatment-emergent adverse events (TEAEs), serious TEAEs, injection site reactions and clinically significant laboratory values and vital signs
Time frame: From Day -1 to Day 85.
Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa
Time frame: On Day 1, Day 43 and Day 85

Study locations

1 site

Clinical Pharmacology of Miami- Site Number : 8400001
Hialeah, Florida 33014, United States

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07646548
Lead sponsor: Sanofi
Collaborators: Regeneron Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 12, 2026
Start date: Jun 11, 2026
Primary completion: Sep 30, 2026 (estimated)
Completion: Sep 30, 2026 (estimated)
Last update: Jul 21, 2026

Study contacts

Angel Lamas, MD

principal investigator · Clinical Pharmacology of Miami (CPMI)

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Sanofi

Start the discussion