What side effects are associated with this type of intervention?

Common treatments for Chikungunya primarily involve supportive care, such as NSAIDs for pain and fever management, and intravenous fluids or corticosteroids for severe cases. Side effects of intravenous treatments, similar to those studied in the SAR440894 trial, can include infusion site reactions, headaches, nausea, and potential allergic reactions. Severe side effects are rare but may include infections or thrombophlebitis.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Chikungunya. The management of Chikungunya primarily focuses on symptomatic relief, including the use of analgesics, antipyretics, and fluids to manage pain and fever. The trial involving SAR440894 is a phase I study evaluating the safety of single ascending intravenous infusions, but there is no direct correlation to Chikungunya treatments, as current approaches do not involve such intravenous therapies.

What other types of research exist?

Promising novel alternatives to SAR440894 for Chikungunya treatment in 2024 include antiviral agents such as Favipiravir and Remdesivir, which have shown broad-spectrum antiviral activity. Additionally, monoclonal antibodies targeting the Chikungunya virus and RNA interference (RNAi) therapies are emerging as potential treatments. These alternatives are in various stages of clinical development and have demonstrated efficacy in preclinical or early clinical studies.

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SAR440894 for Chikungunya Fever

Phase 1

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male subjects (including those with vasectomies) whose partners are of childbearing potential should use condoms with spermicide and not donate sperm for the duration of the study

Male subjects (including those with vasectomies) whose partners are of childbearing potential should use condoms with spermicide and not donate sperm for the duration of the study.

Must not have

Has received any mAb in the past, whether licensed or investigational, or plans to receive a mAb during the study

Potassium, bicarbonate or creatinine results are Grade 1 or higher at either Screening or Day -1/Baseline visits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 150

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since it's a Phase I safety trial for SAR440894 (a new drug), specific side effects aren't listed yet; they're being determined by this study. Common side effects from similar drugs may include reactions at the infusion site or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a male willing to use condoms and not donate sperm during the study.

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I am a man who will use condoms and not donate sperm during the study.

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I am a healthy adult aged 18-45 with a BMI between 18 and 35.

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My veins are suitable for IV infusions and blood tests.

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I am 18-45 years old with a BMI between 18 and 35.

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I have not had surgery to remove my reproductive organs and am not in menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received or plan to receive a monoclonal antibody treatment.

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My kidney function tests are slightly abnormal.

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I have not donated over 500 mL of blood in the last month.

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My blood tests for WBC, platelets, hemoglobin, bilirubin, liver enzymes, and sodium are within normal limits.

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My body weight is under 50 kg.

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I have a known heart condition related to abnormal heart rhythms or heart failure.

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I have not been seriously ill in the last 2 weeks.

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I have had cancer before, but not low-grade skin cancer.

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I haven't taken any experimental drugs recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 150

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 150

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 150 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of changes from baseline in vital signs

Occurrence of clinically significant (CS) changes from baseline in clinical safety laboratory values

Occurrence of clinically significant (CS) changes in ECG parameters from baseline

Secondary study objectives

Changes in concentration of SAR440894 plasma human anti-drug antibody (ADA)

SAR440894 plasma concentration

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR440894

2020

Completed Phase 1

~50

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chikungunya is primarily managed through supportive care, including hydration, pain relief, and anti-inflammatory medications. Common treatments include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and acetaminophen to reduce fever and joint pain. In severe cases, corticosteroids may be used to manage inflammation. The focus on intravenous treatments, similar to those in the SAR440894 trial, is significant for Chikungunya patients as it allows for rapid administration and absorption of medications, potentially providing quicker relief from severe symptoms. This is particularly important in managing acute pain and inflammation, which are hallmark symptoms of Chikungunya.

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