Myelodysplastic Syndrome Clinical Trial

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

Summary

Primary objective

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

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria: Having given written informed consent prior to undertaking any study-related procedure Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

Any participant who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT06326814

Recruitment Status:

Completed

Sponsor:

Sanofi

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There are 2 Locations for this study

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Parexel International Site Number : 8400002
Glendale California, 91206, United States
Parexel International Site Number : 8400003
Baltimore Maryland, 21255, United States

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT06326814

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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