Healthy Volunteers
Conditions
Brief summary
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
Detailed description
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.
Interventions
DRUGSAR441344
Solution for intravenous/subcutaneous injection
DRUGplacebo
Solution for intravenous/subcutaneous injection
BIOLOGICALKeyhole limpet hemocyanin
Subcutaneous Lyophilized powder for reconstitution
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of participants with adverse event(AE) | From baseline to day 127 | Number of participants with AE from baseline to day 127 |
| Part 2: Number of participants with adverse event (AE) | From baseline to day 155 | Number of participants with AE from baseline to day 155 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK parameter: AUClast | From Day 1 to Day 127 | Area under the plasma concentration versus time curve from time zero to the real time |
| Assessment of PK parameter: AUC | Area under the plasma concentration versus time curve extrapolated to infinity | From Day 1 to Day 127 |
| Assessment of PK parameter: AUC0-tau | From day 1 to Day 155 | Area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (336 hours) |
| Assessment of PK parameter: Ctrough | From Day 1 to Day 155 | Plasma concentration observed just before treatment administration during repeated dosing |
| Assessment of PK parameter: t1/2z | From Day 1 to Day 127 and Day 155 | Terminal half-life associated with the terminal slope (λz) |
| Assessment of PK parameter: Cmax | From Day 1 to Day 127 and to Day 155 | Maximum plasma concentration (Cmax) observed |
| Assessment of PK parameter: CLss(/F) | Apparent total body clearance of a drug from the plasma | From day 1 to Day 155 |
| Anti-SAR441344 antibodies | From Day 1 to Day 127 and Day 155 | Number of subjects with treatment emergent anti-drug antibody formation |
| Assessment of anti-KLH IgG and IgM | From Day 1 to Day 127 and Day 155 | Measurement of anti-KLH IgG and IgM levels in response to KLH immunization |
| AE attributed to KLH immunization | From Day 1 to Day 127 and Day 155 | Number of participants with AE attributed to KLH immunization |
| Assessment of PK parameter: CL(/F) | Apparent total body clearance of a drug from the plasma | From Day 1 to Day 127 |
| Assessment of PK parameter: tmax | From Day 1 to Day 127 and Day 155 | First time to reach Cmax (tmax) |
Countries
United States
Outcome results
None listed