Dengue FeverPhase 2NCT03875560
IC14 in Adult Patients With Dengue Fever
A Phase 2 study testing IC14 in people with Dengue Fever, run by Implicit Bioscience.
Trial summary
Randomized, double-blind, placebo-controlled, safety, PK/PD and preliminary efficacy study of intravenous IC14 in adult patients in a dengue-endemic region presenting with fever > 38°C for < 48 hours with a positive NS1 strip assay or reverse-transcriptase polymerase chain reaction assay for dengue virus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dengue Fever
- What is being tested?
- IC14
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fever > 38°C for < 48 hours and clinical presentation consistent with dengue fever.
- Positive NS1 strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR) assay for dengue virus.
- Informed consent form signed and dated by the patient.
- Subject able to give informed consent and able to comply with all study visits and all study procedures.
- Females of childbearing potential should be using and committed to continue using acceptable birth control methods.
- Sexual abstinence (inactivity) for 1 month prior to screening through study completion; or
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- Intrauterine device (IUD) in place for at least 3 months prior to study through study completion; or
- Stable hormonal contraception for at least 3 months prior to study through study completion; or
- Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
- To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses.
Who cannot join
- One or more of the following dengue warning signs and symptoms:
- Intense and continuous abdominal pain (referred pain or on palpation);
- Persistent vomiting;
- Fluid accumulation (ascites, pleural effusion, or pericardial effusion);
- Postural hypotension and/or collapse;
- Painful hepatomegaly > two centimeters below the right costal margin;
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- Mucosal bleeding;
- Major bleeding (hematemesis and/or melena);
- Lethargy and/or irritability;
- Diminished urine output;
- Hypothermia;
- Progressive increase in hematocrit or 20% above baseline or normal for age;
- Abrupt drop in platelets;
- Respiratory discomfort.
- One or more of the following signs and symptoms of severe dengue, such as:
- Severe plasma extravasation, leading to shock evidenced by one or more of the following:
- Tachycardia;
- Cold distal extremities;
- Weak, thready pulse;
- Slow capillary refill (> 2 seconds);
- Pulse pressure < 20 mmHg;
- Tachypnea; or
- Oliguria (<1.5 mL/kg/hr).
- Systolic blood pressure < 90 mmHg or decrease >40 mmHg;
- Cyanosis;
- Fluid accumulation with respiratory discomfort;
- Severe bleeding; or
- Severe organ impairment, evidenced by one or more of the following:
- Liver impairment (AST >1000 U/L, international normalized ratio >1.5);
- Renal impairment (serum creatinine ≥1.5 mg/dL); or
- Myocarditis, pericarditis, or clinical heart failure (by chest x-ray, echocardiography, electrocardiogram, or cardiac enzymes if available).
- Female who is pregnant, lactating or of childbearing potential.
- Self-reported or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the previous 3 months).
- Prior vaccination against dengue fever.
- Significant chronic illness that, in the opinion of the Investigator, would interfere with study validity, conduct or completion.
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of IC14 in Adult Patients With Dengue Fever
Randomized, double-blind, placebo-controlled, safety, PK/PD and preliminary efficacy study of intravenous IC14 in adult patients in a dengue-endemic region presenting with fever > 38°C for < 48 hours with a positive NS1 strip assay or reverse-transcriptase polymerase chain reaction assay for dengue virus.
Read the detailed description
The study will be conducted in two parts and will include an open label phase of a single dose of IC14 (Part A) and a randomized phase of multiple doses of IC14 and placebo (Part B). Up to 52 patients will be enrolled in both parts of the study.
Part A will consist of 12 patients given one of three doses of IC14 as a single dose open-label . Each patient must complete 14 days before the enrollment of subsequent patients. Part A subjects will be hospitalized for 4 days. During and at the end of 4-day admission to the clinical research unit, and on Study Days 5, 6, 7, 14, 21 and 32, Part A patients will have their health status assessed. The last subject in Part A must complete 32 days of participation before Part B of the trial is opened.
Part B consists of 40 patients randomized equally to one of 4 dosing regimens which will include a single dose or multiple doses of IC14 or placebo given at different dosing frequencies. In Part B, Cohort 1 and 2 subjects (single dose) will be inpatient for 4 days and Cohort 3 and 4 subjects (four daily doses) will be inpatient for 5 days. During and at the end of the admission to the clinical research unit, and on Study Days 5, 6, 7, 14, 21 and 32, Part B patients will have their health status assessed.
- Conditions
- Dengue Fever
- Being tested
- IC14, Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC14Biological
recombinant chimeric anti-human CD14 monoclonal antibody
PlaceboDrug
Inactive
| Study group | Role | What they receive |
|---|---|---|
| Part A/Single Dose | Experimental | IC14 0.5, 1.0 or 2.0 mg/kg IV as a single dose (subjects are assigned and not randomized to this arm. When Part A is complete, Enrollment to Part B will commence). Receives: Biological: IC14 |
| Part B/Cohort 1 | Experimental | IC14 4 mg/kg/day IV or placebo IV x 1 day. Receives: Biological: IC14; Drug: Placebo |
| Part B/Cohort 2 | Experimental | IC14 8 mg/kg/day IV or placebo IV x 1 day. Receives: Biological: IC14; Drug: Placebo |
| Part B/Cohort 3 | Experimental | IC14 2 mg/kg/day IV x 1 day followed by IC14 1 mg/kg/day IV x 3 days or placebo IV daily for 4 days. Receives: Biological: IC14; Drug: Placebo |
| Part B/Cohort 4 | Experimental | IC14 4 mg/kg/day IV x 1 day followed by IC14 2 mg/kg/day IV x 3 days or placebo IV daily for 4 days. Receives: Biological: IC14; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (safety, tolerability)
Number of patients with treatment-related adverse events as classified according to MedDRA
Measured: 32 days
Area under the curve of IC14 serum concentration
Area under the curve of IC14 serum concentration
Measured: 14 days
Secondary outcomes (5)
Dengue viral load
Impact of treatment on dengue viral load measured by quantitative viral load and plasma NS1 viral protein
Measured: 32 days
Fever
Impact of treatment on duration of fever
Measured: 32 days
Dengue symptom score
Impact of treatment on dengue symptom severity (0 normal] to 24 [worst])
Measured: 32 days
Disease severity
Impact of treatment on duration of hospitalization; incidence and duration of intensive care unit admission; and incidence of progression to dengue with warning signs or severe dengue
Measured: 32 days
Mortality
Impact of treatment on survival
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: withdrawn, no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implicit Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Agosti, MD, Study director, Implicit Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875560
- Sponsor's protocol ID
- EDF-01
- Status last verified
- Mar 2019
- First submitted
- 16 Aug 2016
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of IC14 in Adult Patients With Dengue Fever
- ClinicalTrials.gov ID
- NCT03875560
- Acronym / sponsor ID
- EDF-01
- Conditions
- Dengue Fever
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn, no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Implicit BioscienceIndustry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind, placebo-controlled, safety, PK/PD and preliminary efficacy study of intravenous IC14 in adult patients in a dengue-endemic region presenting with fever > 38°C for < 48 hours with a positive NS1 strip assay or reverse-transcriptase polymerase chain reaction assay for dengue virus.
Detailed description
The study will be conducted in two parts and will include an open label phase of a single dose of IC14 (Part A) and a randomized phase of multiple doses of IC14 and placebo (Part B). Up to 52 patients will be enrolled in both parts of the study.
Part A will consist of 12 patients given one of three doses of IC14 as a single dose open-label . Each patient must complete 14 days before the enrollment of subsequent patients. Part A subjects will be hospitalized for 4 days. During and at the end of 4-day admission to the clinical research unit, and on Study Days 5, 6, 7, 14, 21 and 32, Part A patients will have their health status assessed. The last subject in Part A must complete 32 days of participation before Part B of the trial is opened.
Part B consists of 40 patients randomized equally to one of 4 dosing regimens which will include a single dose or multiple doses of IC14 or placebo given at different dosing frequencies. In Part B, Cohort 1 and 2 subjects (single dose) will be inpatient for 4 days and Cohort 3 and 4 subjects (four daily doses) will be inpatient for 5 days. During and at the end of the admission to the clinical research unit, and on Study Days 5, 6, 7, 14, 21 and 32, Part B patients will have their health status assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A/Single Dose | Experimental | Biological: IC14IC14 0.5, 1.0 or 2.0 mg/kg IV as a single dose (subjects are assigned and not randomized to this arm. When Part A is complete, Enrollment to Part B will commence). |
| Part B/Cohort 1 | Experimental | Biological: IC14, Drug: PlaceboIC14 4 mg/kg/day IV or placebo IV x 1 day. |
| Part B/Cohort 2 | Experimental | Biological: IC14, Drug: PlaceboIC14 8 mg/kg/day IV or placebo IV x 1 day. |
| Part B/Cohort 3 | Experimental | Biological: IC14, Drug: PlaceboIC14 2 mg/kg/day IV x 1 day followed by IC14 1 mg/kg/day IV x 3 days or placebo IV daily for 4 days. |
| Part B/Cohort 4 | Experimental | Biological: IC14, Drug: PlaceboIC14 4 mg/kg/day IV x 1 day followed by IC14 2 mg/kg/day IV x 3 days or placebo IV daily for 4 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fever > 38°C for < 48 hours and clinical presentation consistent with dengue fever.
- Positive NS1 strip assay or reverse-transcriptase polymerase chain reaction (RT-PCR) assay for dengue virus.
- Informed consent form signed and dated by the patient.
- Subject able to give informed consent and able to comply with all study visits and all study procedures.
- Females of childbearing potential should be using and committed to continue using acceptable birth control methods.
Key exclusion criteria (35 listed)
- One or more of the following dengue warning signs and symptoms:
- One or more of the following signs and symptoms of severe dengue, such as:
- Female who is pregnant, lactating or of childbearing potential.
- Self-reported or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the previous 3 months).
- Prior vaccination against dengue fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IC14recombinant chimeric anti-human CD14 monoclonal antibody | Biological | Part A/Single Dose, Part B/Cohort 1, Part B/Cohort 2, Part B/Cohort 3, Part B/Cohort 4 |
| PlaceboInactive | Drug | Part B/Cohort 1, Part B/Cohort 2, Part B/Cohort 3, Part B/Cohort 4 |
Primary outcome
Incidence of treatment-emergent adverse events (safety, tolerability)
Time frame: 32 days
Number of patients with treatment-related adverse events as classified according to MedDRA
Area under the curve of IC14 serum concentration
Time frame: 14 days
Area under the curve of IC14 serum concentration
5 secondary outcomes
Dengue viral load
Time frame: 32 days
Fever
Time frame: 32 days
Dengue symptom score
Time frame: 32 days
Disease severity
Time frame: 32 days
Mortality
Time frame: 32 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Agosti, MD study director
Implicit Bioscience
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IC14 in people with Dengue Fever, run by Implicit Bioscience.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (safety, tolerability) (time frame: 32 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.