First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The anticipated study duration per participant is up to 14 weeks
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SAR443765 Single dose administration of SAR443765 |
Drug: SAR443765
solution for injection
Drug: Salbutamol or levosalbutamol
metered dose inhaler
|
| Placebo Comparator: Placebo Placebo to match SAR443765 |
Drug: Placebo
solution for injection
Drug: Salbutamol or levosalbutamol
metered dose inhaler
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs) /TEAEs [From baseline up to Day 71]
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures
- Pharmacokinetic (PK) assessment: Cmax [From baseline up to Day 71]
Observed maximum plasma concentration
- Pharmacokinetic (PK) assessment: AUClast [From baseline up to Day 71]
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast
- Pharmacokinetic (PK) assessment: AUC [From baseline up to Day 71]
Area under the serum concentration versus time curve extrapolated to infinity
- Change in Nitric Oxide (FeNO) level [Day 1 and Day 29]
Change from Baseline in FeNO level at Day 29
- Presence of Anti-SAR443765 antibodies (ADA) [From baseline up to Day 71]
Number of participant with SAR443765 antibodies
- Total (free + bound) serum target concentrations of TSLP [From baseline up to Day 71]
Change from baseline in total serum target concentrations of TSLP
- Total (free + bound) serum target concentrations of IL-13 [From baseline up to Day 71]
Change from baseline in total serum target concentrations of IL-13
Eligibility Criteria
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 documented by an asthma control questionnaire-5 (ACQ-5) score of <1.5
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site Number :2760001 | Berlin | Germany | 10117 | |
| 2 | Investigational Site Number :8260001 | Belfast | United Kingdom | BT9 6AD |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PDY16622
- 2021-000356-19
- U1111-1265-6232