Can a single drug stop dengue in its tracks?
NCT ID NCT06528457
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a drug called fenretinide (ISLA101) can prevent or reduce dengue symptoms. Fifteen healthy adults were given either the drug or a placebo before or after being exposed to a weakened dengue virus. Researchers measured virus levels and immune responses over 29 days to see if the drug helps control the infection.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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15 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Jul 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy male and female subjects not of childbearing potential who are 18 years to 55 years of age (inclusive) at the time of consent * Females not of childbearing potential as defined in the following criteria: 1. History of hysterectomy 2. Post-menopausal: i. Natural post-menopausal females with at least 12 months from natural spontaneous amenorrhea and a serum follicle-stimulating hormone (FSH) concentration ≥ 40 IU/L ii. Post-surgical females must have undergone bilateral oophorectomy at least 6 weeks prior to study * Male subjects with female partners of childbearing potential must agree to practice abstinence or use a combination of 2 of the following acceptable birth control methods during the study and for at least 90 days after dosing: 1. Partners with an intrauterine device (IUD) in place for at least 3 months 2. Barrier method (condom or diaphragm) for at least 14 days prior to screening 3. Partners using stable hormonal contraceptive for at least 3 months prior to the study 4. History of vasectomy at least 3 months prior to signing the Informed Consent Form * Ability and willingness to sign informed consent * Passing score on comprehension test of at least 75%, with up to 3 attempts * Available for the study period * Provide consent for release of medical records from primary care physician, college or university, urgent care or emergency room visit Exclusion Criteria: * Known or suspected pregnancy (confirmed via a positive serum human chorionic gonadotropin (hCG) pregnancy test at screening), planned pregnancy during the study period, nursing, or lactation * Men who intend to father a child or donate sperm during the study period, and for 90 days after dosing with study drug * Any disorders of coagulation * Any current malignancy other than non-melanoma skin cancer * Men who intend to father a child during the study period (approximately 120 days) * Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HBsAg) virus, or suspicion of active influenza virus infection * Positive antibodies to dengue virus * Any history of dengue infection or dengue vaccination (licensed or experimental); or planned dengue vaccination during the study period * Recent (in the past 4 weeks) travel to any dengue endemic area or travel to a country with risk of Yellow Fever or Japanese encephalitis transmission * Positive urine screen for cocaine, amphetamines, opiates or methadone * Currently taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) * Active diabetes, active peptic ulcer disease (PUD), chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD) * Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Use of drugs listed in §6.6 that inhibit or induce Cytochrome P450 3A4 (CYP 3A4) enzymes within 30 days prior to administration of study drug and for the duration of Subject participation * Current, or a history of, auto-immune disease other than well controlled Hashimoto's thyroiditis * History of Guillain-Barré syndrome * Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the Subject from participating in the study * Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or an allergy to specific medications/animals for which antigens may be in the virus preparations to include: shellfish allergy, fetal bovine serum, L-glutamine, neomycin and streptomycin * Chronic migraine headaches, defined as more than 15 headache days per month over a 3-month period of which more than 8 are migraines, in the absence of medication over use * Planning to donate blood in the 1 year following inoculation with dengue * Recent blood donation within prior 14 days of inoculation * Receipt of blood products or antibodies within 56 days of inoculation or during the study period * Planned travel during the study period (\~120 days) which would interfere with the ability to complete all study visits * Any laboratory abnormalities prior to inoculation for the tests specified in the protocol, that are considered by the investigator to be clinically significant except those listed in exclusion criteria #25 * subjects with the following grade 2 or greater lab abnormalities: Creatinine; Liver Function Tests - alanine transaminase (ALT), aspartate aminotransferase (AST); Hemoglobin (females and males); white blood count (WBC) decrease; Platelets decreased; prothrombin time (PT); partial thromboplastin time (PTT); Fibrinogen decrease * Significant screening physical examination abnormalities at the discretion of the investigator * Participation (active or follow-up phase) or planned participation in another vaccine, drug, medical device, or medical procedure clinical trial in the 4 weeks prior to this trial or during the trial. * Recent or scheduled receipt of any vaccine 4 weeks prior to or after virus inoculation * Beliefs that restrict the administration of blood products or transfusions * Chronic medical condition that, in the opinion of the investigator, impacts Subject safety * Physician discretion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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SUNY Upstate Medical University
East Syracuse, New York, 13057, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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