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AsthmaPhase 1NCT05366764

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

A Phase 1 study testing SAR443765 and Salbutamol or levosalbutamol in people with Asthma, run by Sanofi at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
SAR443765 and Salbutamol or levosalbutamol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
2 sitesin 2 countries
Study dates
8 Jun 2022to 24 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Germany1 site

  • Investigational Site Number : 2760001

    Berlin

Other trials in Germany

United Kingdom1 site

  • Investigational Site Number : 8260001

    Belfast, BT9 6AD

Other trials in United Kingdom

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SAR443765 in Healthy Adult Participants and of a Single Dose of SAR443765 in Participants With Mild-to-moderate Asthma

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.

Read the detailed description

The anticipated study duration per participant is up to 14 weeks

Conditions
Asthma
Being tested
SAR443765, Placebo, Salbutamol or levosalbutamol
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR443765Drug

    solution for injection

  • PlaceboDrug

    solution for injection

  • Salbutamol or levosalbutamolDrug

    metered dose inhaler

Study groups in NCT05366764
Study groupRoleWhat they receive
SAR443765ExperimentalSingle dose administration of SAR443765
Receives: Drug: SAR443765; Drug: Salbutamol or levosalbutamol
PlaceboPlacebo comparatorPlacebo to match SAR443765
Receives: Drug: Placebo; Drug: Salbutamol or levosalbutamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs) /TEAEs

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

    Measured: From baseline up to Day 71

Secondary outcomes (7)

  1. Pharmacokinetic (PK) assessment: Cmax

    Observed maximum plasma concentration

    Measured: From baseline up to Day 71

  2. Pharmacokinetic (PK) assessment: AUClast

    Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time tlast

    Measured: From baseline up to Day 71

  3. Pharmacokinetic (PK) assessment: AUC

    Area under the serum concentration versus time curve extrapolated to infinity

    Measured: From baseline up to Day 71

  4. Change in Nitric Oxide (FeNO) level

    Change from Baseline in FeNO level at Day 29

    Measured: Day 1 and Day 29

  5. Presence of Anti-SAR443765 antibodies (ADA)

    Number of participant with SAR443765 antibodies

    Measured: From baseline up to Day 71

  6. Total (free + bound) serum target concentrations of TSLP

    Change from baseline in total serum target concentrations of TSLP

    Measured: From baseline up to Day 71

  7. Total (free + bound) serum target concentrations of IL-13

    Change from baseline in total serum target concentrations of IL-13

    Measured: From baseline up to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start8 Jun 2022
  3. Primary completion24 Feb 2023
  4. Study completion24 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05366764
Sponsor's protocol ID
PDY16622
Other IDs
U1111-1265-6232, PDY16622, 2021-000356-19
Status last verified
Sep 2025
First submitted
4 May 2022
Last updated
10 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • 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.

    PubMed 39884759

  • 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.

    PubMed 38924698

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR443765 and Salbutamol or levosalbutamol in people with Asthma, run by Sanofi at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) /TEAEs (time frame: From baseline up to Day 71). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05366764, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.

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