Chronic Obstructive Pulmonary DiseasePhase 1NCT06114238
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
A Phase 1 study testing Itepekimab AI and Itepekimab PFS in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 1 site in United States.
Trial summary
This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Itepekimab AI and Itepekimab PFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2021to 8 Mar 2022
- 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
- Having given written informed consent prior to undertaking any study-related procedure.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- 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
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami Site Number : 8400001
Miami, Florida, 33014
About this study
Official title: A Phase 1, Single-center, Open-label, Randomized, Parallel Group, Single-dose Study to Compare the Pharmacokinetics of Subcutaneous Itepekimab Administered With an Autoinjector Versus Prefilled Syringe in Healthy Participants
This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP).
Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) >18.5 and ≤30 kg/m2.
Read more
Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups:
- Itepekimab administered via AI (test)
- Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (<70 kg, ≥70 to <80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm).
Study duration for each participant is up to approximately 162 days, including:
- Screening period: up to 21 days
- Institutionalization: 2 days including 1 treatment day (Day 1)
- Follow-up period: 140 days (±5 days)
- End of study (EOS): Day 141 (± 5 days)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Itepekimab AI, Itepekimab PFS
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itepekimab AIDrug
Also called SAR440340/REGN3500
Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI
Itepekimab PFSDrug
Also called SAR440340/REGN3500
Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Itepekimab administered via AI Receives: Drug: Itepekimab AI |
| Cohort 2 | Active comparator | Itepekimab administered via PFS Receives: Drug: Itepekimab PFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax
Maximum plasma concentration of itepekimab
Measured: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUClast
AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Measured: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUC
AUC: Area under the plasma concentration versus time curve extrapolated to infinity
Measured: Baseline up to EOS (approximately Day 141)
Secondary outcomes (7)
Assessment of PK parameter of itepekimab: tmax
Time to reach Cmax of itepekimab
Measured: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUC0-28days
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to 28 days
Measured: Baseline up to Day 28
Assessment of PK parameter of itepekimab: t1/2
Terminal half-life associated with the terminal slope (λz)
Measured: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: CL/F
Apparent total body clearance of a drug from the serum
Measured: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: Vss/F
Apparent Volume of Distribution at the steady state
Measured: Baseline up to EOS (approximately Day 141)
Incidence of treatment-emergent anti-itepekimab antibodies responses
Measured: Baseline up to EOS (approximately Day 141)
Number of participants with Adverse Events (including injection site reactions), Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI)
Measured: Baseline up to EOS (approximately Day 141)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start16 Sep 2021
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114238
- Sponsor's protocol ID
- PKM16966
- Other IDs
- U1111-1260-3853, PKM16966
- Status last verified
- Sep 2024
- First submitted
- 24 Oct 2023
- Last updated
- 19 Sep 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Open-label, Randomized, Parallel Group, Single-dose Study to Compare the Pharmacokinetics of Subcutaneous Itepekimab Administered With an Autoinjector Versus Prefilled Syringe in Healthy Participants
- ClinicalTrials.gov ID
- NCT06114238
- Acronym / sponsor ID
- PKM16966
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 2 Nov 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 Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP).
Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) >18.5 and ≤30 kg/m2.
Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups:
- Itepekimab administered via AI (test)
- Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (<70 kg, ≥70 to <80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm).
Study duration for each participant is up to approximately 162 days, including:
- Screening period: up to 21 days
- Institutionalization: 2 days including 1 treatment day (Day 1)
- Follow-up period: 140 days (±5 days)
- End of study (EOS): Day 141 (± 5 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Itepekimab AIItepekimab administered via AI |
| Cohort 2 | Active comparator | Drug: Itepekimab PFSItepekimab administered via PFS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having given written informed consent prior to undertaking any study-related procedure.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Itepekimab AIAlso: SAR440340/REGN3500Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous AI | Drug | Cohort 1 |
| Itepekimab PFSAlso: SAR440340/REGN3500Pharmaceutical form:Solution for injection; Route of administration: Subcutaneous PFS | Drug | Cohort 2 |
Primary outcome
Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax
Time frame: Baseline up to EOS (approximately Day 141)
Maximum plasma concentration of itepekimab
Assessment of PK parameter of itepekimab: AUClast
Time frame: Baseline up to EOS (approximately Day 141)
AUClast: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Assessment of PK parameter of itepekimab: AUC
Time frame: Baseline up to EOS (approximately Day 141)
AUC: Area under the plasma concentration versus time curve extrapolated to infinity
7 secondary outcomes
Assessment of PK parameter of itepekimab: tmax
Time frame: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: AUC0-28days
Time frame: Baseline up to Day 28
Assessment of PK parameter of itepekimab: t1/2
Time frame: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: CL/F
Time frame: Baseline up to EOS (approximately Day 141)
Assessment of PK parameter of itepekimab: Vss/F
Time frame: Baseline up to EOS (approximately Day 141)
Incidence of treatment-emergent anti-itepekimab antibodies responses
Time frame: Baseline up to EOS (approximately Day 141)
Number of participants with Adverse Events (including injection site reactions), Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI)
Time frame: Baseline up to EOS (approximately Day 141)
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 2024.
- PKM16966 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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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.
Clinical Sciences & Operations study director
Sanofi
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 Itepekimab AI and Itepekimab PFS in people with Chronic Obstructive Pulmonary Disease, 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 1 inclusion and 3 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 2024. 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?
Assessment of pharmacokinetic (PK) parameter of itepekimab: Cmax (time frame: Baseline up to EOS (approximately Day 141)). 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 19 Sep 2024.