42 Participants Needed

SAR440894 for Chikungunya Fever

Recruiting at 3 trial locations
MC
KM
Overseen ByKristie Miller
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The available research does not provide specific safety data for SAR440894, but other chikungunya vaccines have been generally well-tolerated in humans, with no significant safety issues identified in trials.12345

How is the drug SAR440894 unique for treating Chikungunya fever?

SAR440894 is unique because there are currently no approved vaccines or antiviral drugs specifically for Chikungunya fever, making it a novel option in the absence of standard treatments.678910

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

You agree to attend all study appointments and follow the study rules.
I use a reliable birth control method or am in a non-male exclusive relationship.
If you are a woman who could become pregnant, you must agree not to donate your eggs during the study.
See 16 more

Exclusion Criteria

Your blood pressure is either too high or too low at the time of screening.
You have a medical condition that makes you ineligible to participate in the study.
I haven't taken any over-the-counter drugs in the last 7 days.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of SAR440894 or placebo via 60-minute intravenous infusion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, pharmacokinetics, and immunogenicity after treatment

150 days

Treatment Details

Interventions

  • Placebo
  • SAR440894
Trial Overview The trial is testing SAR440894 against a placebo in healthy adults. It's given through an IV infusion in increasing doses across groups of participants. Each group has six people getting SAR440894 and two getting placebo. Safety is monitored before moving to higher doses.
Participant Groups
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
20 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
Group II: Cohort 4Experimental Treatment2 Interventions
10 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
Group III: Cohort 3Experimental Treatment2 Interventions
3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
Group IV: Cohort 2Experimental Treatment2 Interventions
1 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.
Group V: Cohort 1Experimental Treatment2 Interventions
0.3 mg/kg of SAR440894 (n=6) or placebo (n=2) administered once during a 60-minute intravenous (IV) infusion. 2 sentinel subjects will receive dosing for review of safety data (SAR440894 n=1, placebo n=1) before remainder of cohort.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

References

Phase II safety and immunogenicity study of live chikungunya virus vaccine TSI-GSD-218. [2022]
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for an inactivated viral vaccine against Chikungunya virus. [2022]
Assessment of immunogenic potential of Vero adapted formalin inactivated vaccine derived from novel ECSA genotype of Chikungunya virus. [2019]
A randomized, double-blinded phase 3 study to demonstrate lot-to-lot consistency and to confirm immunogenicity and safety of the live-attenuated chikungunya virus vaccine candidate VLA1553 in healthy adults. [2023]
Extended Preclinical Safety, Efficacy and Stability Testing of a Live-attenuated Chikungunya Vaccine Candidate. [2019]
Development of a pseudotyped-lentiviral-vector-based neutralization assay for chikungunya virus infection. [2021]
Development of a Novel Chikungunya Virus-Like Replicon Particle for Rapid Quantification and Screening of Neutralizing Antibodies and Antivirals. [2023]
Chikungunya fever: How accurate is the clinical-epidemiological diagnosis compared to the gold standard of molecular and serological laboratory diagnosis? [2021]
A Mouse Model for Studying Post-Acute Arthritis of Chikungunya. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Use of human monoclonal antibodies to treat Chikungunya virus infection. [2014]
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