Healthy VolunteersPhase 1NCT05976386
Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
A Phase 1 study testing Dupilumab (SAR231893) in people with Healthy Volunteers, run by Sanofi at 1 site in United States.
Trial summary
This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dupilumab (SAR231893)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 24 Sep 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants, between 18 and 65 years of age, inclusive.
- Body weight between 65.0 and 95.0 kg, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Having given written informed consent prior to undertaking any study-related procedure.
Who cannot join
- Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, 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.
- Presence or history of drug or biologic hypersensitivity, or allergic disease diagnosed and treated by a physician (excluding seasonal allergy).
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Smoking regularly and unable to stop smoking during the inpatient portion of the study (occasional smoker can be enrolled).
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- If female, pregnancy (defined as positive β-human chorionic gonadotropin (HCG) blood test) or breastfeeding.
- Any biologics (antibody or its derivatives) given within 4 months before inclusion or within 5 half-lives (whichever takes longer).
- Participation in any previous clinical trial of dupilumab.
- Participation in any clinical research study evaluating another investigational drug or therapy in which the inclusion visit for the current study will be within 30 days of receiving the drug or 5 elimination half-lives (whichever is longer).
- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
- The above information is not intended to contain all considerations relevant to a patient'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
Miami, Florida, 33014
About this study
Official title: A Randomized, Open-label, Parallel Design, Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
This is a parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years.
The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.
Read the detailed description
Duration per participant is up to 64 days
- Conditions
- Healthy Volunteers
- Being tested
- Dupilumab (SAR231893)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dupilumab (SAR231893)Drug
Also called REGN668
Injection solution Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| New dupilumab product | Experimental | A single subcutaneous injection on Day 1 Receives: Drug: Dupilumab (SAR231893) |
| Current dupilumab product | Active comparator | A single subcutaneous injection on Day 1 Receives: Drug: Dupilumab (SAR231893) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration of functional dupilumab (Cmax)
Measured: Pre-dose on Day 1 up to Day 43
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
Measured: Pre-dose on Day 1 up to Day 43
Secondary outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Day 1 up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start8 Jun 2021
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976386
- Sponsor's protocol ID
- PKM17324
- Other IDs
- U1111-1266-7002
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2023
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Design, Single Dose Study to Compare the Pharmacokinetics of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults
- ClinicalTrials.gov ID
- NCT05976386
- Acronym / sponsor ID
- PKM17324
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 4 Aug 2023 (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 parallel group, treatment, Phase 1, open-label, 2-arm study to demonstrate pharmacokinetic comparability between subcutaneous (SC) single dose of new dupilumab product and SC single dose of current dupilumab product in male and female healthy participants aged 18 to 65 years.
The estimated duration is up to 21 days of screening period, followed by the treatment day with a follow-up treatment period of 42 days until the end of study (EOS) visit. Total duration from screening to EOS will be 64 days maximum.
Detailed description
Duration per participant is up to 64 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New dupilumab product | Experimental | Drug: Dupilumab (SAR231893)A single subcutaneous injection on Day 1 |
| Current dupilumab product | Active comparator | Drug: Dupilumab (SAR231893)A single subcutaneous injection on Day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants, between 18 and 65 years of age, inclusive.
- Body weight between 65.0 and 95.0 kg, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Having given written informed consent prior to undertaking any study-related procedure.
Key exclusion criteria (12 listed)
- Presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, 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.
- Presence or history of drug or biologic hypersensitivity, or allergic disease diagnosed and treated by a physician (excluding seasonal allergy).
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
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 (SAR231893)Also: REGN668Injection solution Subcutaneous | Drug | Current dupilumab product, New dupilumab product |
Primary outcome
Maximum serum concentration of functional dupilumab (Cmax)
Time frame: Pre-dose on Day 1 up to Day 43
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
Time frame: Pre-dose on Day 1 up to Day 43
1 secondary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 up to Day 43
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 19 Sep 2025.
- PKM17324 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (SAR231893) 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 12 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 19 Sep 2025. 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?
Maximum serum concentration of functional dupilumab (Cmax) (time frame: Pre-dose on Day 1 up to Day 43). 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 19 Sep 2025.