- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803308
A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
A Phase 1a/1b Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of SB 9200 in Treatment Naïve HCV Infected Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Nucleus Network, Austin Hospital
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Melbourne, Victoria, Australia, 3004
- Nucleus Network, The Alfred Hospital
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Linear Clinical Research, The Queen Elizabeth II Medical Centre
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Christchurch, New Zealand, 8011
- Primorus Clinical Trials Ltd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must provide written informed consent before any assessment is performed.
- Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Males or females of non-childbearing potential between the ages of 18 and 60 years, inclusive.
- Must have HCV and laboratory evidence of HCV infection for at least six months before the Screening Visit.
- Must have HCV-1 (1a or 1b or non-sub-typeable HCV-1), HCV-2 or HCV-3, as applicable for a given cohort.
- Subjects must have a plasma HCV RNA >5 log10 IU/mL (100,000 IU/mL).
- Must have fibrosis of Stage 2 or lower by Ishak or Metavir scoring system or equivalent as evidenced by a recent (within two years of screening) liver biopsy (i.e. no more than moderate fibrosis). If a recent liver biopsy is not available, Fibroscan of < 8.5 kilopascals at screening.
- Must have negative human immunodeficiency virus (HIV) and Hepatitis B screening test results.
- Must have a body mass index (BMI) of 18-32 kg/m2 (inclusive).
- Must have screening laboratory values within the reference ranges or if outside the normal range, not clinically significant as judged by the Investigator. ALT and aspartate aminotransferase (AST) must be within 2x the upper limit of normal.
- Must not consume grapefruit or grapefruit-related citrus fruits or juice from seven days prior to the first dose of study drug until collection of the final PK blood sample at 14 days after the last dose of study drug.
- Must be able to communicate with site personnel and understand instructions.
Exclusion Criteria:
- Any previous treatment with an investigational or approved drug or drug regimen for the treatment of HCV. Note: SB 9200 is excluded from this criterion, i.e. subjects who complete Part A of the study will be eligible to participate in Part B of the study.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Use of nonprescription drugs, vitamins and dietary supplements within 14 days or five half-lives (whichever is longer) prior to the trial dose medication. Changes to prescription medication within 14 days prior to the first dose of study medication (i.e. only stable prescription medications are permitted whilst on study).
- History of intercurrent illness (e.g., upper respiratory illness with fever) within five days prior to the first dose of study drug.
- History of illicit or controlled substance abuse or alcohol abuse within one year before the Screening Visit (with the exception of cannabinoids).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening or baseline.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.
- Women of child-bearing potential.
- Fertile males, defined as all males physiologically capable of conceiving offspring unless the subject and partner of child bearing potential agree to comply with acceptable contraception and the female partner is not lactating.
- Prior liver biopsy (at any time in the past), indicating Stage 3 or higher fibrosis by Ishak or Metavir scoring system or equivalent (i.e. greater than moderate fibrosis).
- Any other cause of significant liver disease in addition to HCV, which may include, but is not limited to, malignancy with hepatic involvement, hepatitis B, drug or alcohol related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, or primary biliary cirrhosis.
- Evidence or history or clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Blood donation of approximately 500 mL or significant blood loss within 56 days prior to dosing.
- Any other medical or psychiatric condition or laboratory abnormality which, in the view of the Investigator, is likely to interfere with the study or put the subject at risk.
- Concurrent participation in another clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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. Intervention: SB9200 |
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.
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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 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: Up to 35 days
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Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, treatment-emergent adverse events, vital signs (blood pressure, heart rate, respiratory rate).
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Up to 35 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic profile of SB9200
Time Frame: Up to 35 days
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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.
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Up to 35 days
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Pharmacokinetic and Pharmacodynamic relationship of SB9200
Time Frame: Up to 35 days
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Correlation between SB9200 exposure and Hepatitis C RNA level at doses from 100 mg to 1500 mg.
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Up to 35 days
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Effect of food on exposure of SB 9200
Time Frame: Up to 35 days
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Comparison of exposure to SB9200 in fed and fasted states.
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Up to 35 days
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Short Term Antiviral Efficacy
Time Frame: Up to 35 days
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Short term antiviral efficacy of ascending doses of SB 9200 monotherapy given for up to 14 days to treatment naïve subjects with Hepatitis C.
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Up to 35 days
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Viral Resistance
Time Frame: Up to 35 days
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Viral resistance and describe any resistant mutants that appear during Investigational Product administration.
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Up to 35 days
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IL28B Genotype
Time Frame: Up to 35 days
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Association of IL28B genotype (CC, CT or TT) with virologic response to SB 9200 at the chosen dose.
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Up to 35 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Exploratory: IFN Expression and IFN pathways
Time Frame: Up to 35 days
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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.
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Up to 35 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Donald Mitchell, F-star Therapeutics, Inc.
- Principal Investigator: Alexander Thompson, MD, PhD, Nucleus Network, The Alfred Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SB12-9200-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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