The purpose of this study is to compare the safety and tolerability of ascending doses of SB 9200 given for up to 14 days to subjects with chronic Hepatitis C infection.
This is a First-in-human, Two-stage, Multi-centre study. Part A is an open-label, single ascending dose study in fed or fasted subjects and Part B is a randomized, placebo-controlled multiple ascending dose study. The study is designed to evaluate the safety and tolerability of ascending doses of SB 9200 given as monotherapy for up to 14 days to subjects with chronic Hepatitis C infection, and to determine the pharmacokinetic and pharmacodynamic relationship over this dose range.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.
Part B randomised 6:2 (active:placebo) using recommended Part B starting dose, and ascending to up to 1500mg for 7-14 days of dosing.
Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
Nucleus Network, Austin Hospital
Heidelberg, Victoria, Australia
Nucleus Network, The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research, The Queen Elizabeth II Medical Centre
Nedlands, Western Australia, Australia
Primorus Clinical Trials Ltd
Christchurch, New Zealand
Safety
Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, treatment-emergent adverse events, vital signs (blood pressure, heart rate, respiratory rate).
Time frame: Up to 35 days
Pharmacokinetic profile of SB9200
Pharmacokinetic parameters and the PK profile of SB 9200 at doses from 100 mg to 1500 mg given for up to 14 days to subjects with Hepatitis C.
Time frame: Up to 35 days
Pharmacokinetic and Pharmacodynamic relationship of SB9200
Correlation between SB9200 exposure and Hepatitis C RNA level at doses from 100 mg to 1500 mg.
Time frame: Up to 35 days
Effect of food on exposure of SB 9200
Comparison of exposure to SB9200 in fed and fasted states.
Time frame: Up to 35 days
Short Term Antiviral Efficacy
Short term antiviral efficacy of ascending doses of SB 9200 monotherapy given for up to 14 days to treatment naïve subjects with Hepatitis C.
Time frame: Up to 35 days
Viral Resistance
Viral resistance and describe any resistant mutants that appear during Investigational Product administration.
Time frame: Up to 35 days
IL28B Genotype
Association of IL28B genotype (CC, CT or TT) with virologic response to SB 9200 at the chosen dose.
Time frame: Up to 35 days
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