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

NCT05366764 | Completed Phase 1

• 3 other identifiers: PDY16622U1111-1265-62322021-000356-19
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs) /TEAEs

  Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)

  From baseline up to Day 71

Secondary Outcomes (7)

• Pharmacokinetic (PK) assessment: Cmax

  From baseline up to Day 71

• Pharmacokinetic (PK) assessment: AUClast

  From baseline up to Day 71

• Pharmacokinetic (PK) assessment: AUC

  From baseline up to Day 71

• Change in Nitric Oxide (FeNO) level

  Day 1 and Day 29

• Presence of Anti-SAR443765 antibodies (ADA)

  From baseline up to Day 71

Study Arms (2)

SAR443765

EXPERIMENTAL

Single dose administration of SAR443765

Drug: SAR443765; Drug: Salbutamol or levosalbutamol

Placebo

PLACEBO COMPARATOR

Placebo to match SAR443765

Drug: Placebo; Drug: Salbutamol or levosalbutamol

Interventions

SAR443765 DRUG

solution for injection

SAR443765

Placebo DRUG

solution for injection

Placebo

Salbutamol or levosalbutamol DRUG

metered dose inhaler

Placebo; SAR443765

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site Number : 2760001

Berlin, Germany

Location

Investigational Site Number : 8260001

Belfast, BT9 6AD, United Kingdom

Location

Related Publications (2)

• Deiteren A, Krupka E, Bontinck L, Imberdis K, Conickx G, Bas S, Patel N, Staudinger HW, Suratt BT. A proof-of-mechanism trial in asthma with lunsekimig, a bispecific NANOBODY molecule. Eur Respir J. 2025 Apr 24;65(4):2401461. doi: 10.1183/13993003.01461-2024. Print 2025 Apr.

  PMID: 39884759 RESULT

• Deiteren A, Bontinck L, Conickx G, Vigan M, Dervaux N, Gassiot M, Bas S, Suratt B, Staudinger H, Krupka E. A first-in-human, single and multiple dose study of lunsekimig, a novel anti-TSLP/anti-IL-13 NANOBODY(R) compound, in healthy volunteers. Clin Transl Sci. 2024 Jun;17(6):e13864. doi: 10.1111/cts.13864.

  PMID: 38924698 DERIVED

Related Links

• PDY16622 Plain Language Results Summary

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 8, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); DE (1)