First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants (NCT05366764) | Clinical Trial Compass
CompletedPhase 1
First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants
Germany, United Kingdom36 participantsStarted 2022-06-08
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 s…
What they're measuring
1
Number of participants with adverse events (AEs) /TEAEs