Your session is about to expire
← Back to Search
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 150
Awards & highlights
Study Summary
This trial will test the safety of a new drug, SAR440894, given to healthy adults aged 18-45 in ascending doses. There will be five cohorts of 8 subjects each, 6 receiving the drug and 2 receiving placebo, and 2 sentinel subjects who will be dosed first. The trial will last approximately 150 days.
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.Check my eligibility
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.See study design
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 belowSelect...
I am a male willing to use condoms and not donate sperm during the study.
Select...
I am a man who will use condoms and not donate sperm during the study.
Select...
I am a healthy adult aged 18-45 with a BMI between 18 and 35.
Select...
My veins are suitable for IV infusions and blood tests.
Select...
I am 18-45 years old with a BMI between 18 and 35.
Select...
I have not had surgery to remove my reproductive organs and am not in menopause.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of adverse events (AEs)
Occurrence of changes from baseline in vital signs
Occurrence of clinically significant (CS) changes from baseline in clinical safety laboratory values
+2 moreSecondary outcome measures
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.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,195 Total Patients Enrolled
4 Trials studying Chikungunya
5,697 Patients Enrolled for Chikungunya
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You agree to attend all study appointments and follow the study rules.Your blood pressure is either too high or too low at the time of screening.I use a reliable birth control method or am in a non-male exclusive relationship.You have a medical condition that makes you ineligible to participate in the study.If you are a woman who could become pregnant, you must agree not to donate your eggs during the study.I haven't taken any over-the-counter drugs in the last 7 days.You have a recent history of drug or alcohol abuse, or significant mental health issues within the past year.I have received or plan to receive a monoclonal antibody treatment.I am using effective birth control starting 30 days before and until the end of the study.You have used any products containing nicotine within the last 30 days before the study.I am a male willing to use condoms and not donate sperm during the study.You are currently enrolled in another clinical trial that involves taking medication.My kidney function tests are slightly abnormal.I haven't taken any prohibited medications in the last 14 days.I am a man who will use condoms and not donate sperm during the study.I have not donated over 500 mL of blood in the last month.My blood tests for WBC, platelets, hemoglobin, bilirubin, liver enzymes, and sodium are within normal limits.My body weight is under 50 kg.I understand the study details and have signed the consent form.I am a healthy adult aged 18-45 with a BMI between 18 and 35.I can stay in the hospital for at least 3 days after getting the study treatment.My veins are suitable for IV infusions and blood tests.I have received a blood transfusion in the last 4 months.I have a known heart condition related to abnormal heart rhythms or heart failure.I have not been seriously ill in the last 2 weeks.I have had cancer before, but not low-grade skin cancer.I am 18-45 years old with a BMI between 18 and 35.I have not had surgery to remove my reproductive organs and am not in menopause.I haven't taken any experimental drugs recently.My veins are suitable for IV infusions and blood tests.You are currently breastfeeding and cannot stop during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 5
- Group 2: Cohort 3
- Group 3: Cohort 4
- Group 4: Cohort 2
- Group 5: Cohort 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical experiment actively welcoming participants?
"Yes, the latest information on clinicaltrials.gov confirms that this investigation is currently seeking volunteers for research. The study was first advertised on October 14th 2020 and has since been revised as of November 23rd 2022. 40 individuals are expected to be recruited from two distinct medical facilities."
Answered by AI
Has SAR440894 obtained governmental sanctioning from the FDA?
"Owing to the fact that this is an early phase study, our experts at Power judged SAR440894's safety as a 1 on their scale. This conclusion was made due to insufficient data regarding both efficacy and security levels."
Answered by AI
What is the aggregate population of participants for this research?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, which was initially announced on October 14th 2020, is actively recruiting participants. The recruitment process requires 40 patients from 2 different medical centres."
Answered by AI
Is the age eligibility for this trial limited to individuals under 20 years of age?
"Participants fitting the specified age range of 18 to 45 are eligible for this trial, while 3 other trials cater respectively to minors and those 65 years old or older."
Answered by AI
What criteria must potential participants fulfill to join this trial?
"Those hoping to be selected for this study must have a diagnosis of chikungunya virus and fall between the age parameters of 18-45. The total number of participants being recruited is 40 individuals."
Answered by AI
Who else is applying?
What state do they live in?
Oklahoma
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Pharmaceutical Product Development - Orlando Clinical Research Unit
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger