Healthy VolunteerPhase 1NCT05976360
A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants
A Phase 1 study testing Dupilumab (SAR231893) in people with Healthy Volunteer, run by Sanofi at 2 sites in United States.
Trial summary
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- 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
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Nov 2014to 17 Jan 2015
- 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.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body weight between 70.0 and 90.0 kg, inclusive.
- Having given written informed consent prior to undertaking any study-related procedure.
Who cannot join
- Any history or 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 (more than twice a month).
- Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -1.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
- History of light-headedness or syncope during blood collection or injection of medications.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
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- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- If female, pregnancy (defined as positive β-human chorionic gonadotropin blood test) or breast-feeding.
- Any history or 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.
- Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or 5 elimination half-lives of the respective investigational drug, whichever is longer, of the inclusion visit.
- Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- 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
2 sites in 1 country.
United States2 sites
Prism Research-Site Number:840002
Saint Paul, Minnesota, 55144
Biokinetic Clinical Applications-Site Number:840003
Springfield, Missouri, 65802
About this study
Official title: A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses
This is a phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks.
Read the detailed description
Duration per participant is up to 11 weeks.
- Conditions
- Healthy Volunteer
- 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
Dupilumab (SAR231893)Drug
Also called REGN668
Injection solution, subcutaneous.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab drug product 1 | Active comparator | A single subcutaneous injection on Day 1 Receives: Drug: Dupilumab (SAR231893) |
| Dupilumab drug product 2 | Experimental | 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 observed: Cmax
Measured: Up to Day 57
Time to reach Cmax (tmax)
Measured: Up to Day 57
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
Measured: Up to Day 57
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to Day 57
Incidence of anti-dupilumab antibodies (ADA)
Measured: Up to Day 57
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 start2 Nov 2014
- Primary completion17 Jan 2015
- Study completion17 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 38 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
- NCT05976360
- Sponsor's protocol ID
- PKM14161
- Other IDs
- U1111-1290-9436
- Status last verified
- 24 Jul 2023
- First submitted
- 28 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel Design Study of the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products After Administration of Single Subcutaneous Doses
- ClinicalTrials.gov ID
- NCT05976360
- Acronym / sponsor ID
- PKM14161
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 2 Nov 2014 (actual)
- Primary completion
- 17 Jan 2015 (actual)
- Study completion
- 17 Jan 2015 (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 phase 1, single subcutaneous dose study to evaluate safety and pharmacokinetics of 2 different dupilumab drug product in healthy volunteers. The duration per participant is up to 11 weeks.
Detailed description
Duration per participant is up to 11 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dupilumab drug product 1 | Active comparator | Drug: Dupilumab (SAR231893)A single subcutaneous injection on Day 1 |
| Dupilumab drug product 2 | Experimental | 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.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body weight between 70.0 and 90.0 kg, inclusive.
- Having given written informed consent prior to undertaking any study-related procedure.
Key exclusion criteria (12 listed)
- Any history or 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 (more than twice a month).
- Blood donation or collection totaling more than 250 mL (including collections during study screening) within 2 months before inclusion on Day -1.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
- History of light-headedness or syncope during blood collection or injection of medications.
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 | Dupilumab drug product 1 |
| Dupilumab (SAR231893)Also: REGN668Injection solution, subcutaneous. | Drug | Dupilumab drug product 2 |
Primary outcome
Maximum serum concentration observed: Cmax
Time frame: Up to Day 57
Time to reach Cmax (tmax)
Time frame: Up to Day 57
Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast)
Time frame: Up to Day 57
2 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to Day 57
Incidence of anti-dupilumab antibodies (ADA)
Time frame: Up to Day 57
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 4 Aug 2023.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Volunteer, run by Sanofi at 2 sites 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 observed: Cmax (time frame: Up to Day 57). The study lists 3 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 4 Aug 2023.