First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
The anticipated study duration per participant is up to 14 weeks
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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