SAR440894 for Chikungunya Fever
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications. Prescription medications like immunosuppressives, immune modulators, and oral corticosteroids are not allowed 14 days before the study and until Day 56. Nonprescription drugs and supplements are not allowed 7 days before the study and until Day 28, unless approved by the study doctor.
Is SAR440894 safe for human use?
How is the drug SAR440894 unique for treating Chikungunya fever?
What is the purpose of this trial?
This trial tests the safety of a new drug, SAR440894, in healthy adults aged 18 to 45. The drug is given through an IV drip to see how the body reacts and if there are any side effects.
Eligibility Criteria
Healthy adults aged 18 to 45 with a BMI between 18 and 35 kg/m^2 can join this trial. They must understand the consent form, agree to study visits, avoid Chikungunya virus areas, use effective contraception, not donate blood or reproductive cells during the study. Excluded are those with certain heart rates, weights, infections like hepatitis/HIV, high caffeine/alcohol/nicotine use before the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single ascending dose of SAR440894 or placebo via 60-minute intravenous infusion
Follow-up
Participants are monitored for safety, pharmacokinetics, and immunogenicity after treatment
Treatment Details
Interventions
- Placebo
- SAR440894
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor