SAR440894 for Chikungunya Fever

No longer recruiting at 3 trial locations

Overseen By Kristie Miller

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Immunosuppressives, Corticosteroids, NSAIDs, others

Disqualifiers: Renal dysfunction, Hypertension, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment, SAR440894, for Chikungunya fever. The researchers aim to ensure the treatment's safety when administered in increasing doses through an IV (a tube that delivers medicine into a vein) to healthy adults. Individuals who are generally healthy, have a BMI between 18 and 35, and can commit to all study visits may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 there any evidence suggesting that SAR440894 is likely to be safe for humans?

Research has shown that SAR440894, a monoclonal antibody treatment, is being tested for chikungunya fever. This Phase 1 trial aims to determine the treatment's safety for people. Researchers are closely monitoring responses to different doses.

Currently, detailed safety information for SAR440894 is not available. However, its inclusion in a Phase 1 study indicates sufficient potential in lab tests for human trials. These early trials focus on tolerance, beginning with low doses to observe bodily reactions.

No specific side effects have been publicly reported for this treatment so far, suggesting that any reactions might be mild or similar to those of other chikungunya treatments. As testing progresses, more safety information will emerge. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SAR440894 is unique because it targets Chikungunya fever using a monoclonal antibody approach, which is different from the current treatments focused on symptom management, such as pain relievers and fever reducers. Researchers are excited about SAR440894 because it directly targets the virus, potentially offering a more effective and faster way to combat the disease. This innovative approach could significantly reduce the impact of Chikungunya fever, providing relief to patients much sooner than existing treatments.

What evidence suggests that SAR440894 might be an effective treatment for Chikungunya Fever?

Research shows that SAR440894 is a monoclonal antibody. It targets the E2 envelope protein of the chikungunya virus, which the virus needs to infect human cells. By blocking this protein, SAR440894 might prevent the virus from spreading in the body. This trial will test different dosages of SAR440894, with participants receiving either the investigational treatment or a placebo. Although direct evidence from human studies on SAR440894 is not yet available, similar treatments have shown promise in treating chikungunya infections. Other vaccines and treatments for chikungunya have generally been safe for people. This suggests that SAR440894 could be effective, but more research is needed to confirm its benefits. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cohort 5 Experimental Treatment 2 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 4 Experimental Treatment 2 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 3 Experimental Treatment 2 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 2 Experimental Treatment 2 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 1 Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. withpower.com withpower.com/trial/phase-1-chikungunya-fever-9-2020-363f6

SAR440894 for Chikungunya Fever · Info for Participants The available research does not provide specific safety data for SAR440894, but other chikungunya vaccines have been generally well-tolerated in humans, with no ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04441905

NCT04441905 | Phase 1 Study of SAR440894 vs Placebo Biological : SAR440894. One time 60-minute IV infusion of SAR440894 monoclonal antibody (IgG1) directed against the E2 envelope protein of chikungunya virus.

3. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(24)00085-1/fulltext

Chikungunya crisis in the Americas: a comprehensive call ... A study published in “The Lancet Regional Health–Americas” emphasises that chikungunya infection frequently results in chronic arthralgia, affecting the quality ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11007399/

Developing a Prototype Pathogen Plan and Research ... Only 1 alphavirus, chikungunya virus (CHIKV), has shown sustained amplification in humans after emergence from nonhuman primate (NHP)-amplified ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11189168/

Clinical outcomes of chikungunya: A systematic literature ... The percentage of patients developing chronic disease ranged from 16% in a study conducted during an outbreak in Chennai, India [24] to 100% in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7883954/

Prophylactic strategies to control chikungunya virus infection ... SAR440894 monoclonal antibody (IgG1) directed ... Phase II safety and immunogenicity study of live chikungunya virus vaccine TSI-GSD-218.

7. canada.ca canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment/chikungunya-virus.html

Chikungunya virus: Infectious substances pathogen safety ... These Pathogen Safety Data Sheets, regulated under Workplace Hazardous Materials Information System (WHMIS) legislation, are produced for ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2667193X24000851

Chikungunya crisis in the Americas: a comprehensive call ... Currently, there are two active trials seeking participants: a phase 1 trial exploring SAR440894 and another studying the effect of methotrexate. ... Daniel, D.A. ...