This is a 3-part, parallel group treatment, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics after sequential single and multiple ascending doses of SAR443765 in healthy adult participants, and after a single dose of SAR443765 in participants with mild-to-moderate asthma.
The anticipated study duration per participant is up to 14 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Investigational Site Number : 2760001
Berlin, Germany
Investigational Site Number : 8260001
Belfast, United Kingdom
Number of participants with adverse events (AEs) /TEAEs
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Time frame: From baseline up to Day 71
Pharmacokinetic (PK) assessment: Cmax
Observed maximum plasma concentration
Time frame: From baseline up to Day 71
Pharmacokinetic (PK) assessment: AUClast
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
Time frame: From baseline up to Day 71
Pharmacokinetic (PK) assessment: AUC
Area under the serum concentration versus time curve extrapolated to infinity
Time frame: From baseline up to Day 71
Change in Nitric Oxide (FeNO) level
Change from Baseline in FeNO level at Day 29
Time frame: Day 1 and Day 29
Presence of Anti-SAR443765 antibodies (ADA)
Number of participant with SAR443765 antibodies
Time frame: From baseline up to Day 71
Total (free + bound) serum target concentrations of TSLP
Change from baseline in total serum target concentrations of TSLP
Time frame: From baseline up to Day 71
Total (free + bound) serum target concentrations of IL-13
Change from baseline in total serum target concentrations of IL-13
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From baseline up to Day 71