A Phase 1 interventional study of SAR441344 and placebo in Healthy Volunteers, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.
Sponsored by Sanofi · Phase 1, Interventional, and Treatment
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
- Having given written informed consent prior to undertaking any study-related procedure.
Exclusion criteria
- Any subject 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.
Single or multiple Ascending dose of SAR441344 Dose 1 administered intravenously and/or subcutaneously
Drug: SAR441344 · Biological: Keyhole limpet hemocyanin
matching placebo
Drug: placebo · Biological: Keyhole limpet hemocyanin
Solution for intravenous/subcutaneous injection
Solution for intravenous/subcutaneous injection
Subcutaneous Lyophilized powder for reconstitution
Part 1: Number of participants with adverse event(AE)
Number of participants with AE from baseline to day 127
Time frame: From baseline to day 127
Part 2: Number of participants with adverse event (AE)
Number of participants with AE from baseline to day 155
Time frame: From baseline to day 155
Assessment of PK parameter: Cmax
Maximum plasma concentration (Cmax) observed
Time frame: From Day 1 to Day 127 and to Day 155
Assessment of PK parameter: tmax
First time to reach Cmax (tmax)
Time frame: From Day 1 to Day 127 and Day 155
Assessment of PK parameter: AUClast
Area under the plasma concentration versus time curve from time zero to the real time
Time frame: From Day 1 to Day 127
Assessment of PK parameter: AUC
From Day 1 to Day 127
Time frame: Area under the plasma concentration versus time curve extrapolated to infinity
Assessment of PK parameter: AUC0-tau
Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours)
Time frame: From day 1 to Day 155
Assessment of PK parameter: Ctrough
Plasma concentration observed just before treatment administration during repeated dosing
Time frame: From Day 1 to Day 155
Assessment of PK parameter: t1/2z
Terminal half-life associated with the terminal slope (λz)
Time frame: From Day 1 to Day 127 and Day 155
Assessment of PK parameter: CL(/F)
From Day 1 to Day 127
Time frame: Apparent total body clearance of a drug from the plasma
Assessment of PK parameter: CLss(/F)
From day 1 to Day 155
Time frame: Apparent total body clearance of a drug from the plasma
Anti-SAR441344 antibodies
Number of subjects with treatment emergent anti-drug antibody formation
Time frame: From Day 1 to Day 127 and Day 155
Assessment of anti-KLH IgG and IgM
Measurement of anti-KLH IgG and IgM levels in response to KLH immunization
Time frame: From Day 1 to Day 127 and Day 155
AE attributed to KLH immunization
Number of participants with AE attributed to KLH immunization
Time frame: From Day 1 to Day 127 and Day 155
Plan to share: 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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi