First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2023-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma

NCT01472757

Asthma

COMPLETED PHASE2/PHASE3

A Clinical Trial in Healthy Volunteers and Patients With Mild Asthma to Investigate a New Medicine (AZD4604) for the Treatment of Asthma

NCT04769869

Asthma

COMPLETED PHASE1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

NCT04772365

Asthma

COMPLETED PHASE1

Phase1, Placebo-Controlled, Randomized, Double-blind, Single-ascending Dose Study in Healthy Subjects.

NCT02616770

Asthma

COMPLETED PHASE1

Safety, Tolerability, and Efficacy of AIN457 in Patients With Uncontrolled Asthma

NCT01478360

Asthma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The anticipated study duration per participant is up to 14 weeks

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAR443765

Single dose administration of SAR443765

Group Type EXPERIMENTAL

SAR443765

Intervention Type DRUG

solution for injection

Salbutamol or levosalbutamol

Intervention Type DRUG

metered dose inhaler

Placebo

Placebo to match SAR443765

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

solution for injection

Salbutamol or levosalbutamol

Intervention Type DRUG

metered dose inhaler

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SAR443765

solution for injection

Intervention Type DRUG

Placebo

solution for injection

Intervention Type DRUG

Salbutamol or levosalbutamol

metered dose inhaler

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes