NCT05366764

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

The anticipated study duration per participant is up to 14 weeks

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	SAR443765	solution for injection
DRUG	Placebo	solution for injection
DRUG	Salbutamol or levosalbutamol	metered dose inhaler

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2022-05-09
• Last updated: 2025-09-10

Locations

2 sites across 2 countries: Germany, United Kingdom