The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Investigational site
Newark, New Jersey, United States
Number of participants with adverse events/treatment-emergent adverse events/adverse events of special interest
Time frame: Baseline up to end of study (EOS) (Day 89)
Assessment of PK parameter: Maximum observed concentration (Cmax)
Time frame: Baseline up to EOS (Day 89)
Assessment of PK parameter: First time to reach Cmax (tmax)
Time frame: Baseline up to EOS (Day 89)
Assessment of PK parameter: Partial area under the serum concentration time curve (AUC)
Time frame: Baseline up to EOS (Day 89)
Immunogenicity: evaluate the presence of anti-SAR442501 antibodies
Time frame: Baseline up to EOS (Day 89)
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