Healthy VolunteerPhase 1NCT05876767
Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Doses of SAR444336 in Healthy Adult Participants
A Phase 1 study testing SAR444336 in people with Healthy Volunteer, run by Sanofi at 2 sites in Netherlands.
Trial summary
This phase 1 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a first step in clinical development prior to administering this new investigational medicinal… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- SAR444336
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesNetherlands
- Study dates
- 15 Oct 2021to 12 Dec 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants between 18 and 55 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Laboratory values within normal range unless the abnormality is considered not clinical relevant by the investigator. The following parameters, however, must be within normal range: platelet count, and CRP. ALT, AST, total bilirubin (unless the participant has documented or suspected Gilbert syndrome) should be <1.25 ULN and serum creatinine should be < ULN.
- Eosinophils <500 cells/µL
- Normal vital signs after 10 minutes resting in supine position
- Standard 12-lead ECG parameters after 10 minutes resting in supine position in the normal ranges and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant.
- Body weight between 50 - 110 kg (inclusive) and body mass index (BMI) between 18 - 30 kg/m2 (inclusive) at screening.
- Only for part 2: Fitzpatrick skin type I - III
Who cannot join
- Any disease associated with immune system dysfunction.
- Known polyethylene glycol allergy
- Only for Part 2: Known seafood allergy
- Any current active viral, bacterial or fungal infection or any medically relevant infection having occurred within 3 weeks before inclusion.
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, autoimmune, systemic, ocular, or infectious disease, or signs of acute illness that would pose an unacceptable risk to the subject in the opinion of the investigator.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month).
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- Blood donation >500 mL within 2 months before inclusion.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥30 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician, except for history of mild allergic diseases which are not active at the time of inclusion and considered not clinically relevant in the opinion of the investigator.
- History or presence of drug or alcohol abuse.
- Smoking regularly more than 10 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).
- Excessive consumption of beverages containing xanthine bases.
- Presence or history of any atopic disease.
- for Part 1: Non-live booster COVID-19 vaccination within 14 days before randomization. First (and second, if applicable) COVID-19 vaccinations are not allowed within 4 weeks before randomization.
- for Part 2: Non-live vaccines including Covid-19: last administration of a vaccine within 4 weeks before randomization.
- Live vaccines: Last administration of a vaccine within 3 months before randomization; Immunomodulatory medication within 60 days before screening.
- Only for Part 2: Participants with known previous exposure to KLH.
- Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days (except COVID-19 booster vaccination) and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, anti-HIV1 and anti HIV2 Ab.
- Positive result on urine drug screen.
- Positive alcohol breath test.
- 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.
Netherlands2 sites
Investigational Site Number :5280002
Groningen, Provincie Groningen, 9728 NZ
Investigational Site Number :5280001
Leiden, Leiden, 2333 CL
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Subcutaneous Doses of SAR444336 in Healthy Adult Participants
This phase 1 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a first step in clinical development prior to administering this new investigational medicinal product (IMP) to patients.
Read the detailed description
The anticipated study duration per participant is up to 10 weeks in Part 1.
- Screening: 2 to 28 days prior to dosing (Day -28 to Day -2)
- Treatment period: Day -1 to Day 29 post dose including
- Institutionalization: Day -1 until Day 8
- Ambulant period including repeat PK and PD blood sampling and ambulant visits: Day 9 to Day 29
- Follow-up period: Day 30 to Day 43
The anticipated study duration per participant is up to 17 weeks in Part 2.
- Screening: 2 to 28 days prior to dosing (Day -28 to Day -2)
- Treatment period: Day -1 to Day 57 (Q2W/3 doses or Q4W/2 doses) or Day -1 to Day 85 (Q4W/3 doses), or Day -1 to Day 50 (Q3W) including
- Institutionalization: Day -1 until Day 3
- Ambulant period including repeat PK and PD blood sampling, ambulant visits and 24 hours institutionalization after 2nd and/or 3rd dose: Day 4 to Day 57 (Q2W/3 doses, Q4W/2 doses), Day 4 to Day 85 (Q4W/3 doses) or Day 50 (Q3W)
- Follow-up period: Day 58 to Day 71 (Q2W/3 doses or Q4W/2 doses), Day 71 to Day 85 (Q4W/3 doses) or Day 51 to Day 64 (Q3W)
- Conditions
- Healthy Volunteer
- Being tested
- SAR444336, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR444336Drug
Single or repeated dose subcutaneous injection
PlaceboDrug
Single or repeated dose subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SAR444336 | Experimental | SAR444336 Receives: Drug: SAR444336 |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of subjects with treatment-emergent adverse events (TEAEs)
Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)
Measured: Until Day 43
Part 2: Number of subjects with treatment-emergent adverse events (TEAEs)
Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)
Measured: Until Day 85
Secondary outcomes (7)
Plasma PK parameters: Cmax
Maximum plasma concentration observed
Measured: Until Day 29 and Day 85
Plasma PK parameters: tmax
Time to reach Cmax
Measured: Until Day 29 and Day 85
Plasma PK parameters: AUClast
Area under the plasma concentration versus time curve over the dosing interval from time 0 until the last concentration above the limit of quantification
Measured: Until Day 29 and Day 85
Plasma PK parameters: AUC
Area under the plasma concentration versus time curve extrapolated to infinity
Measured: Until Day 29 and Day 85
Plasma PK parameters: t1/2z
Terminal half-life
Measured: Until Day 29 and Day 85
Plasma PK parameters: CL/F
Apparent total body clearance after a single extravascular dose
Measured: Until Day 29 and Day 85
Anti-SAR444336 antibodies
Measured: Until Day 29 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 posted25 May 2023
- Study start15 Oct 2021
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876767
- Sponsor's protocol ID
- TDU17072-TDR17161
- Status last verified
- Sep 2025
- First submitted
- 17 May 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single and Repeated Subcutaneous Doses of SAR444336 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05876767
- Acronym / sponsor ID
- TDU17072-TDR17161
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 25 May 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 study will assess the safety and tolerability, and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SAR444336 in healthy subjects following single- and repeated-dose administrations as a first step in clinical development prior to administering this new investigational medicinal product (IMP) to patients.
Detailed description
The anticipated study duration per participant is up to 10 weeks in Part 1.
- Screening: 2 to 28 days prior to dosing (Day -28 to Day -2)
- Treatment period: Day -1 to Day 29 post dose including
- Institutionalization: Day -1 until Day 8
- Ambulant period including repeat PK and PD blood sampling and ambulant visits: Day 9 to Day 29
- Follow-up period: Day 30 to Day 43
The anticipated study duration per participant is up to 17 weeks in Part 2.
- Screening: 2 to 28 days prior to dosing (Day -28 to Day -2)
- Treatment period: Day -1 to Day 57 (Q2W/3 doses or Q4W/2 doses) or Day -1 to Day 85 (Q4W/3 doses), or Day -1 to Day 50 (Q3W) including
- Institutionalization: Day -1 until Day 3
- Ambulant period including repeat PK and PD blood sampling, ambulant visits and 24 hours institutionalization after 2nd and/or 3rd dose: Day 4 to Day 57 (Q2W/3 doses, Q4W/2 doses), Day 4 to Day 85 (Q4W/3 doses) or Day 50 (Q3W)
- Follow-up period: Day 58 to Day 71 (Q2W/3 doses or Q4W/2 doses), Day 71 to Day 85 (Q4W/3 doses) or Day 51 to Day 64 (Q3W)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR444336 | Experimental | Drug: SAR444336SAR444336 |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female participants between 18 and 55 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
- Laboratory values within normal range unless the abnormality is considered not clinical relevant by the investigator. The following parameters, however, must be within normal range: platelet count, and CRP. ALT, AST, total bilirubin (unless the participant has documented or suspected Gilbert syndrome) should be <1.25 ULN and serum creatinine should be < ULN.
- Eosinophils <500 cells/µL
- Normal vital signs after 10 minutes resting in supine position
Key exclusion criteria (22 listed)
- Any disease associated with immune system dysfunction.
- Known polyethylene glycol allergy
- Only for Part 2: Known seafood allergy
- Any current active viral, bacterial or fungal infection or any medically relevant infection having occurred within 3 weeks before inclusion.
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, autoimmune, systemic, ocular, or infectious disease, or signs of acute illness that would pose an unacceptable risk to the subject in the opinion of the investigator.
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 |
|---|---|---|
| SAR444336Single or repeated dose subcutaneous injection | Drug | SAR444336 |
| PlaceboSingle or repeated dose subcutaneous injection | Drug | Placebo |
Primary outcome
Part 1: Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: Until Day 43
Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)
Part 2: Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: Until Day 85
Clinical laboratory evaluations including eosinophils, procalcitonin, and c-reactive protein (CRP), Vital signs, 12-lead electrocardiogram (ECG)
7 secondary outcomes
Plasma PK parameters: Cmax
Time frame: Until Day 29 and Day 85
Plasma PK parameters: tmax
Time frame: Until Day 29 and Day 85
Plasma PK parameters: AUClast
Time frame: Until Day 29 and Day 85
Plasma PK parameters: AUC
Time frame: Until Day 29 and Day 85
Plasma PK parameters: t1/2z
Time frame: Until Day 29 and Day 85
Plasma PK parameters: CL/F
Time frame: Until Day 29 and Day 85
Anti-SAR444336 antibodies
Time frame: Until Day 29 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 16 Sep 2025.
- TDU17072 Plain Language Results SummaryLink provided by the sponsor.
- TDR17161 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.
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 SAR444336 in people with Healthy Volunteer, run by Sanofi at 2 sites in Netherlands.
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 8 inclusion and 22 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 16 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 2 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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?
Part 1: Number of subjects with treatment-emergent adverse events (TEAEs) (time frame: Until 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 16 Sep 2025.