IC14 in Adult Patients With Dengue Fever
- Conditions
- Dengue Fever
- Interventions
- Biological: IC14Drug: Placebo
- Registration Number
- NCT03875560
- Lead Sponsor
- Implicit Bioscience
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Part B/Cohort 2 Placebo IC14 8 mg/kg/day IV or placebo IV x 1 day. Part B/Cohort 1 IC14 IC14 4 mg/kg/day IV or placebo IV x 1 day. Part A/Single Dose IC14 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). Part B/Cohort 3 IC14 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. Part B/Cohort 4 IC14 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. Part B/Cohort 1 Placebo IC14 4 mg/kg/day IV or placebo IV x 1 day. Part B/Cohort 2 IC14 IC14 8 mg/kg/day IV or placebo IV x 1 day. Part B/Cohort 3 Placebo 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. Part B/Cohort 4 Placebo 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.
- Primary Outcome Measures
Name Time Method Area under the curve of IC14 serum concentration 14 days Area under the curve of IC14 serum concentration
Incidence of treatment-emergent adverse events (safety, tolerability) 32 days Number of patients with treatment-related adverse events as classified according to MedDRA
- Secondary Outcome Measures
Name Time Method Dengue viral load 32 days Impact of treatment on dengue viral load measured by quantitative viral load and plasma NS1 viral protein
Dengue symptom score 32 days Impact of treatment on dengue symptom severity (0 normal\] to 24 \[worst\])
Disease severity 32 days 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
Mortality 32 days Impact of treatment on survival
Fever 32 days Impact of treatment on duration of fever