Healthy VolunteersPhase 1NCT07646548
Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
A Phase 1 study testing Dupilumab coformulated with berahyaluronidase alfa and Dupilumab in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dupilumab coformulated with berahyaluronidase alfa and Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami- Site Number : 8400001
Hialeah, Florida, 33014
About this study
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
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
- Being tested
- Dupilumab coformulated with berahyaluronidase alfa, Dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab coformulated with berahyaluronidase alfaBiological
Also called SAR231893, Dupixent
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
DupilumabBiological
Also called SAR231893, Dupixent
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1 Receives: Biological: Dupilumab coformulated with berahyaluronidase alfa |
| Treatment B | Experimental | Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1 Receives: Biological: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
Cmax: Maximum concentration observed in serum
Measured: 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
Measured: 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
Measured: From Day -1 to Day 85.
Number of participants with antidrug antibody to dupilumab and berahyaluronidase alfa
Measured: On Day 1, Day 43 and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start11 Jun 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Angel Lamas, MD, Principal investigator, Clinical Pharmacology of Miami (CPMI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646548
- Sponsor's protocol ID
- PKM20425
- Other IDs
- U1111-1331-0702
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07646548
- Acronym / sponsor ID
- PKM20425
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Biological: Dupilumab coformulated with berahyaluronidase alfaParticipants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1 |
| Treatment B | Experimental | Biological: DupilumabParticipants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dupilumab coformulated with berahyaluronidase alfaAlso: SAR231893, DupixentPharmaceutical form: Solution for injection Route of administration: Subcutaneous injection | Biological | Treatment A |
| DupilumabAlso: SAR231893, DupixentPharmaceutical form: Solution for injection Route of administration: Subcutaneous injection | Biological | Treatment B |
Primary outcome
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab
Time frame: From Day 1 to Day 85 (end of study)
Cmax: Maximum concentration observed in serum
PK parameter in serum: AUClast of dupilumab
Time frame: From Day 1 to Day 85 (end of study)
AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- PKM20425 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Lamas, MD principal investigator
Clinical Pharmacology of Miami (CPMI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dupilumab coformulated with berahyaluronidase alfa and Dupilumab in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) parameter in serum: Cmax of dupilumab (time frame: From Day 1 to Day 85 (end of study)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.