first-in-human study of sar443765 in healthy participants and in asthmatic participants

Conditions: Asthma

Summary: 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

Eligibility criteria:
inclusion criteria: * diagnosis of asthma for at least 12 months and confirmed at screening based on the global initiative for asthma (gina) 2020 guidelines * controlled asthma defined as no more than 1 canister of rescue inhaler per month over the last 3 months prior to baseline * elevated feno level defined as ≥25 ppb * participants, using as-needed saba, ics-naïve or with existing stable treatment (at least for 3 months prior to screening) with low to medium daily dose ics (≤500 mcg of fluticasone propionate or comparable ics daily dosage) potentially in combination with a laba and/or lama as second controller, and/or with stable daily leukotriene receptor antagonist, leukotriene synthesis inhibitor and/or chromones * prebronchodilator forced expiratory volume in 1 second (fev1) ≥60% of predicted normal * reversibility of at least 12% and 200 ml in fev1 or forced vital capacity (fvc) after administration of 4 puffs (400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening or documented history of a reversibility test that meets this criteria within 5 years prior to screening or documented positive response to methacholine challenge (a decrease in fev1 by 20% \[pc20\] of \<8 mg/ml) within 5 years prior to screening visit * body weight between 50.0 and 105.0 kg, inclusive, if male, and between 40.0 and 95.0 kg, inclusive, if female, body mass index between 18.0 and 32.0 kg/m2 * male participants are eligible to participate if they use condom during study period * a female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a woman of non-childbearing potential (woncbp) or is a woman of childbearing potential (wocbp) and agrees to use a contraceptive method that is highly effective * a wocbp must have a negative highly sensitive pregnancy test within 36 hours before the first administration of study intervention exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any clinically relevant abnormal findings in medical history, physical examination, vital signs, 12-lead ecg. * chronic lung disease, or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts. * history of life-threatening asthma, asthma exacerbation or use of systemic steroid within 3 months prior to screening visit * worsening of asthma or respiratory infection within the last 6 weeks prior screening visit. * symptomatic postural hypotension,history or presence of drug or alcohol abuse, current smoker or previous smoker with a smoking history \>10 pack-years. * excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day). note: other inclusion/exclusion criteria may apply. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.