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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
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 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)
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
2,203 Previous Clinical Trials
4,036,685 Total Patients Enrolled
25 Trials studying Rheumatoid Arthritis
7,234 Patients Enrolled for Rheumatoid Arthritis
Clinical Sciences & OperationsStudy DirectorSanofi
872 Previous Clinical Trials
2,020,778 Total Patients Enrolled
16 Trials studying Rheumatoid Arthritis
3,118 Patients Enrolled for Rheumatoid Arthritis
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