A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 1a/1b Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SB 9200 in Treatment Naïve HCV Infected Adults|
- Safety [ Time Frame: Up to 35 days ] [ Designated as safety issue: Yes ]Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, treatment-emergent adverse events, vital signs (blood pressure, heart rate, respiratory rate).
- Pharmacokinetic profile of SB9200 [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]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.
- Pharmacokinetic and Pharmacodynamic relationship of SB9200 [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Correlation between SB9200 exposure and Hepatitis C RNA level at doses from 100 mg to 1500 mg.
- Effect of food on exposure of SB 9200 [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Comparison of exposure to SB9200 in fed and fasted states.
- Short Term Antiviral Efficacy [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Short term antiviral efficacy of ascending doses of SB 9200 monotherapy given for up to 14 days to treatment naïve subjects with Hepatitis C.
- Viral Resistance [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Viral resistance and describe any resistant mutants that appear during Investigational Product administration.
- IL28B Genotype [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Association of IL28B genotype (CC, CT or TT) with virologic response to SB 9200 at the chosen dose.
- Exploratory: IFN Expression and IFN pathways [ Time Frame: Up to 35 days ] [ Designated as safety issue: No ]Blood samples will be collected for potential exploratory evaluation of correlations between SB9200 dose and Interferon (IFN) expression, and induction of signalling proteins in IFN pathways such as Interferon Regulatory Factor (IRF)-3, IRF-7, Interferon Stimulated Gene 15 (ISG15) and Extra Erythrocytically expressed haemoglobin (EEEH) levels in plasma.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Experimental Part A
Experimental: Part A: Part A will use a single ascending dose protocol in small, open-label cohorts to determine the starting dose for Part B in the potentially therapeutic range.
Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.
Experimental: Experimental Part B
Experimental: Part B: Part B will use a multiple ascending dose protocol to further explore the safety, tolerability, pharmacokinetics and pharmacodynamics of SB9200 over 7-14 days of dosing.
Intervention: SB9200 and Placebo
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.Drug: Placebo
Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803308
|Contact: Naomi Croll, PhD||+61 (02) 8437 email@example.com|
|Contact: David Fuller, MD||+61 (02) 8437 firstname.lastname@example.org|
|Nucleus Network, Austin Hospital||Recruiting|
|Heidelberg, Victoria, Australia, 3084|
|Nucleus Network, The Alfred Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Australia, Western Australia|
|Linear Clinical Research, The Queen Elizabeth II Medical Centre||Recruiting|
|Nedlands, Western Australia, Australia, 6009|
|Primorus Clinical Trials Ltd||Recruiting|
|Christchurch, New Zealand, 8011|
|Study Director:||Donald Mitchell||Spring Bank Pharmaceuticals, Inc|
|Principal Investigator:||Alexander Thompson, MD, PhD||Nucleus Network, The Alfred Hospital|