A Phase 2a, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of Repeated Oral Doses of JNJ-64281802 Against Dengue Serotype 3 Infection in a Dengue Human Challenge Model in Healthy Adult Participants

  • STATUS
    Recruiting
  • sponsor
    NIH
Updated on 9 December 2021
Accepts healthy volunteers

Summary

This research will study an investigational drug called JNJ-64281802 (JNJ study drug) so we can find out if it works to prevent infection with DENV. We are also studying its safety and how it acts in people’s bodies.

To do this, we will give you the JNJ study drug (or a placebo) for 5 days before giving you a shot of a dengue virus called rDEN3Δ30 (referred to as DENV-3). You will continue to take the JNJ study drug until Study Day 21 (or for 26 days total). You will be asked to return to the clinic every day including weekends from Day -3 through Day 20 to receive JNJ study drug. These visits will last about 60 – 90 minutes.

We want to find out if the JNJ study drug will keep you from having symptoms of dengue virus. We hope to find a medication we can safely give to people in the future to prevent dengue virus infection. 

Description

For more information please call 410-955-7283 or visit centerforimmunizationresearch.org

Details
Condition Johns Hopkins, *Healthy Patient Studies, Paid Studies in Baltimore, Research Studies, Healthy Volunteers, Johns Hopkins paid studies, Johns Hopkins CIR is recruiting for a paid Dengue dosing study, Paid research studies near me, Healthy Volunteers Needed for Paid Research Study at Johns Hopkins in Baltimore, Paid studies in Baltimore, Center for Immunization Research, Dengue Johns Hopkins, CIR
Clinical Study IdentifierTX289033
SponsorNIH
Last Modified on9 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy males and females
Must be 18-50 years old
No previous history of flavivirus infection
Available for the duration of the study
Available for study visits for 29 consecutive days (including weekends)
Available for 2 2-day inpatient stays during the study
Must have BMI between 18-30
Willing to use effective contraception for the duration of the study
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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