Clinical trial NCT05845996: Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects
Official title: A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: Number of participants with adverse event(AE)
timeFrame: From baseline to day 127
measure: Part 2: Number of participants with adverse event (AE)
timeFrame: From baseline to day 155
Secondary outcomes:
measure: Assessment of PK parameter: Cmax
timeFrame: From Day 1 to Day 127 and to Day 155
measure: Assessment of PK parameter: tmax
timeFrame: From Day 1 to Day 127 and Day 155
measure: Assessment of PK parameter: AUClast
timeFrame: From Day 1 to Day 127
measure: Assessment of PK parameter: AUC
timeFrame: Area under the plasma concentration versus time curve extrapolated to infinity
measure: Assessment of PK parameter: AUC0-tau
timeFrame: From day 1 to Day 155
measure: Assessment of PK parameter: Ctrough
timeFrame: From Day 1 to Day 155
measure: Assessment of PK parameter: t1/2z
timeFrame: From Day 1 to Day 127 and Day 155
measure: Assessment of PK parameter: CL(/F)
timeFrame: Apparent total body clearance of a drug from the plasma
measure: Assessment of PK parameter: CLss(/F)
timeFrame: Apparent total body clearance of a drug from the plasma
measure: Anti-SAR441344 antibodies
timeFrame: From Day 1 to Day 127 and Day 155
measure: Assessment of anti-KLH IgG and IgM
timeFrame: From Day 1 to Day 127 and Day 155
measure: AE attributed to KLH immunization
timeFrame: From Day 1 to Day 127 and Day 155
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD-Site Number:8400001
state: Texas
Study officials:
References: