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Monoclonal Antibodies

SAR441566 for Rheumatoid Arthritis

Phase 1

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 to day 5 of each period (5 days per period)

Awards & highlights

Study Summary

This trial studies the safety & effectiveness of a new drug in healthy Japanese adults to see how it affects the body.

Eligible Conditions

Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 to day 5 of each period (5 days per period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 to day 5 of each period (5 days per period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 5 of each period (5 days per period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUC

Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: AUClast

Assessment of plasma pharmacokinetic (PK) parameters for SAR441566: Cmax

Secondary outcome measures

Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAR441566Experimental Treatment1 Intervention

Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR441566

2023

Completed Phase 1

~110

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SanofiLead Sponsor

2,163 Previous Clinical Trials

3,512,470 Total Patients Enrolled

25 Trials studying Rheumatoid Arthritis

7,234 Patients Enrolled for Rheumatoid Arthritis

Clinical Sciences & OperationsStudy DirectorSanofi

857 Previous Clinical Trials

2,019,289 Total Patients Enrolled

16 Trials studying Rheumatoid Arthritis

3,118 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join this clinical experiment?

"Eligibility criteria for this medical trial requires sufferers of rheumatoid arthritis aged between 18-55. Currently, 8 participants are needed to complete the study."

Answered by AI

Does this medical study permit participants over the age of 35?

"Within this medical trial's inclusion criteria, only individuals aged 18 to 55 can apply. There are 53 studies for minors and 346 other trials available for seniors of 65 years or older."

Answered by AI

Are any new participants being welcomed for this clinical experiment?

"Clinicaltrials.gov reports that this trial is open for patient recruitment, which began on May 15th 2023 and was last modified on the 26th of same month."

Answered by AI

Has SAR441566 achieved the necessary authorisation from the FDA?

"Due to the limited safety data available at this Phase 1 trial, SAR441566 has been assigned an initial risk score of 1."

Answered by AI

How many individuals are being recruited for participation in this trial?

"Indeed, available evidence on clinicaltrials.gov confirms that this trial is actively recruiting patients. This study was initially advertised on May 15th 2023 and the latest update occurred on May 26th 2023. A total of 8 individuals are required to be recruited from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.

2023. "A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05858788.