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A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:
A First-in-human, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single Doses of SAR443809 in Healthy Adult Subjects

Clinical Trial Summary

Primary objective - The tolerability and safety of SAR443809 Secondary - The PK parameters of SAR443809 - The PD activity of SAR443809 - The immunogenicity of SAR443809

Clinical Trial Description

Screening: up to 56 days (Day -56 to Day -2). Treatment: 1 day (treatment on Day 1, study observation period from Day -1 to Day 3). Follow-up and end of study: 105 days after IMP administration (follow up visits from Day 5 to Day 78; End of study visit on Day 106). Total study duration for each participant: approximately 23 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06326814
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date October 11, 2021
Completion date May 5, 2023
View Details
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