An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge (NCT05048875) | Clinical Trial Compass
CompletedPhase 2
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
United States56 participantsStarted 2022-02-03
Plain-language summary
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a placebo with respect to its antiviral activity in healthy adult participants inoculated with Dengue Serotype 3.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female.
✓. 18 to 55 years of age, inclusive, at time of screening.
✓. Healthy on the basis of physical examination, medical history, and vital signs performed at screening.
✓. Healthy on the basis of clinical laboratory tests performed at screening.
✓. Must pass the comprehension assessment indicating that the participant understands the purpose, procedures, and potential risks and benefits of the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and answered the potential participant's questions.
✓. Must have a body mass index between 18.0 and 35.0 kg/m2, inclusive.
✓. Must have a normal electrocardiogram (ECG, test which displays a person's heartbeat) at screening.
✓. Must have a blood pressure (after lying face up for greater than or equal to 5 minutes) between 90 and 140 mmHg systolic and less than or equal to 90 mmHg diastolic at screening.
Exclusion criteria
✕. History of liver or renal impairment; significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, constipation lasting greater than 2 days), endocrine, neurologic, hematologic, rheumatologic, neoplastic, autoimmune, or metabolic disturbances.
✕. Known allergies, hypersensitivity, or intolerance to the study drug (JNJ-64281802) or its inactive substances, or an acute, life threatening allergic reaction or swelling following study drug administration.
What they're measuring
1
Assess the Antiviral Activity of the Study Drug (JNJ 64281802) Versus Placebo in Terms of Reduction of Dengue Infection.
Timeframe: 28 days
Trial details
NCT IDNCT05048875
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. History of a severe allergic reaction or anaphylaxis (which is a severe, potentially life-threatening allergic reaction).
✕. Taken any substances or therapies that are not allowed before the first dose of study drug.
✕. Received an investigational intervention or participated in another investigational clinical trial (including investigational vaccines) within 6 months before first dose of study drug, or is currently enrolled in an investigational study, or is planning to be enrolled in an investigational study within 90 days after last dose of study drug. With the exception of participation in COVID-19 vaccine trials and receipt COVID-19 vaccines licensed or under Emergency Use Authorization which can be received at any time.
✕. Persons of childbearing potential only: Pregnant as determined by a positive pregnancy blood test, breastfeeding, or planning to become pregnant during the study or within 90 days after last dose of study drug.
✕. Plans to impregnate and help conceive a child during the study or within 90 days after last dose of study drug.
✕. Any condition for which, in the opinion of the study doctor, participation would not be in the best interest of the participant.