IC14 in Adult Patients With Dengue Fever

NCT03875560 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: EDF-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dengue Fever

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events (safety, tolerability)

  Number of patients with treatment-related adverse events as classified according to MedDRA

  32 days

• Area under the curve of IC14 serum concentration

  Area under the curve of IC14 serum concentration

  14 days

Secondary Outcomes (5)

• Dengue viral load

  32 days

• Fever

  32 days

• Dengue symptom score

  32 days

• Disease severity

  32 days

• Mortality

  32 days

Study Arms (5)

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).

Biological: IC14

Part B/Cohort 1

EXPERIMENTAL

IC14 4 mg/kg/day IV or placebo IV x 1 day.

Biological: IC14; Drug: Placebo

Part B/Cohort 2

EXPERIMENTAL

IC14 8 mg/kg/day IV or placebo IV x 1 day.

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.

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.

Biological: IC14; Drug: Placebo

Interventions

IC14 BIOLOGICAL

recombinant chimeric anti-human CD14 monoclonal antibody

Part A/Single Dose; Part B/Cohort 1; Part B/Cohort 2; Part B/Cohort 3; Part B/Cohort 4

Placebo DRUG

Inactive

Part B/Cohort 1; Part B/Cohort 2; Part B/Cohort 3; Part B/Cohort 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• 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:

Sponsors & Collaborators

• Implicit Bioscience: lead

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Jan Agosti, MD

  Implicit Bioscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: March 14, 2019
• Study Start: May 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 5, 2026

Record last verified: 2019-03