SAR440894 for Chikungunya

Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit, Durham, NC
ChikungunyaSAR440894 - Biological
Eligibility
18 - 45
All Sexes
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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.

Eligible Conditions
  • Chikungunya

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

5 Primary · 3 Secondary · Reporting Duration: Day 1 through Day 150

Day 150
Changes in concentration of SAR440894 plasma human anti-drug antibody (ADA)
Occurrence of adverse events (AEs)
Occurrence of changes from baseline in clinical safety laboratory values
Occurrence of changes from baseline in vital signs
Occurrence of clinically significant changes in ECG parameters from baseline
Occurrence of serious adverse events (SAEs)
Presence/absence of SAR440894 plasma human anti-drug antibody (ADA)
SAR440894 plasma concentration

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

5 Treatment Groups

Cohort 5
1 of 5
Cohort 4
1 of 5
Cohort 1
1 of 5
Cohort 2
1 of 5
Cohort 3
1 of 5

Experimental Treatment

40 Total Participants · 5 Treatment Groups

Primary Treatment: SAR440894 · Has Placebo Group · Phase 1

Cohort 5Experimental Group · 2 Interventions: Placebo, SAR440894 · Intervention Types: Other, Biological
Cohort 4Experimental Group · 2 Interventions: Placebo, SAR440894 · Intervention Types: Other, Biological
Cohort 1Experimental Group · 2 Interventions: Placebo, SAR440894 · Intervention Types: Other, Biological
Cohort 2Experimental Group · 2 Interventions: Placebo, SAR440894 · Intervention Types: Other, Biological
Cohort 3Experimental Group · 2 Interventions: Placebo, SAR440894 · Intervention Types: Other, Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through day 150

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,183 Previous Clinical Trials
4,980,858 Total Patients Enrolled
4 Trials studying Chikungunya
5,697 Patients Enrolled for Chikungunya

Eligibility Criteria

Age 18 - 45 · All Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Oklahoma100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.