This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.
Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1 to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days. While in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5, patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
100 mg capsules, 400 mg loading dose 200 mg bid
Capsules of identical appearance containing starch
Singapore General Hospital
Singapore, Singapore
Virological Log Reduction (Virological Endpoint)
Time frame: 4 days
Fever Reduction (Clinical Endpoint)
Time frame: 4 days
Safety-Proportion of patients experiencing adverse events and serious adverse events
The proportion of patients experiencing adverse events and serious adverse events
Time frame: 14 days
Quantitative NS1 and NS1 clearance
NS1 non-structural protein 1
Time frame: 14 days
Hematology
Leukocytes, platelets, hematocrit
Time frame: 14 days
Pharmacokinetics - Clearance of drug (L/hr)
Clearance of drug (L/hr)
Time frame: 5 days
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