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Monoclonal Antibodies

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

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
No Placebo-Only Group

Summary

This trial tests a new drug called SAR441566 in healthy Japanese men aged 18-55 to see how it moves through their bodies and if it is safe.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Number of participants with adverse events (AE) and treatment-emergent adverse events (TEAEs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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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
2,216 Previous Clinical Trials
4,047,622 Total Patients Enrolled
26 Trials studying Rheumatoid Arthritis
10,734 Patients Enrolled for Rheumatoid Arthritis
Clinical Sciences & OperationsStudy DirectorSanofi
877 Previous Clinical Trials
2,022,806 Total Patients Enrolled
16 Trials studying Rheumatoid Arthritis
3,118 Patients Enrolled for Rheumatoid Arthritis
~4 spots leftby Dec 2025
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