Hepatitis C InfectionPhase 1NCT01803308
A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
A Phase 1 study testing SB9200 in people with Hepatitis C Infection, run by Syneos Health at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- SB9200
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Nucleus Network, Austin Hospital
Heidelberg, Victoria, 3084
Nucleus Network, The Alfred Hospital
Melbourne, Victoria, 3004
Linear Clinical Research, The Queen Elizabeth II Medical Centre
Nedlands, Western Australia, 6009
About this study
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
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.
Read the detailed description
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.
- Conditions
- Hepatitis C Infection
- Being tested
- SB9200, Placebo
- Keywords
- Hepatitis C Infection, Treatment Naïve, Chronic, First In Human, Single Ascending Dose, Multiple Ascending Dose
- Medical subject headings
- Hepatitis C, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB9200Drug
Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.
SB9200Drug
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.
PlaceboDrug
Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Part A | Experimental | 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 Receives: Drug: SB9200 |
| Experimental Part B | Experimental | 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 Receives: Drug: SB9200; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, treatment-emergent adverse events, vital signs (blood pressure, heart rate, respiratory rate).
Measured: Up to 35 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: Up to 35 days
Effect of food on exposure of SB 9200
Comparison of exposure to SB9200 in fed and fasted states.
Measured: 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.
Measured: Up to 35 days
Viral Resistance
Viral resistance and describe any resistant mutants that appear during Investigational Product administration.
Measured: Up to 35 days
IL28B Genotype
Association of IL28B genotype (CC, CT or TT) with virologic response to SB 9200 at the chosen dose.
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- F-star Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Donald Mitchell, Study director, F-star Therapeutics, Inc.Alexander Thompson, MD, PhD, Principal investigator, Nucleus Network, The Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803308
- Sponsor's protocol ID
- SB12-9200-101
- Status last verified
- Aug 2014
- First submitted
- 27 Feb 2013
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01803308
- Acronym / sponsor ID
- SB12-9200-101
- Conditions
- Hepatitis C Infection
- Keywords
- Hepatitis C Infection, Treatment Naïve, Chronic, First In Human, Single Ascending Dose, Multiple Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- F-star Therapeutics, Inc.
- Study start
- Mar 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Part A | Experimental | Drug: SB9200Experimental: 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 |
| Experimental Part B | Experimental | Drug: SB9200, Drug: PlaceboExperimental: 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB9200Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg. | Drug | Experimental Part A |
| SB9200Part 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 | Experimental Part B |
| PlaceboPart B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient. | Drug | Experimental Part B |
Primary outcome
Safety
Time frame: Up to 35 days
Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, treatment-emergent adverse events, vital signs (blood pressure, heart rate, respiratory rate).
6 secondary outcomes
Pharmacokinetic profile of SB9200
Time frame: Up to 35 days
Pharmacokinetic and Pharmacodynamic relationship of SB9200
Time frame: Up to 35 days
Effect of food on exposure of SB 9200
Time frame: Up to 35 days
Short Term Antiviral Efficacy
Time frame: Up to 35 days
Viral Resistance
Time frame: Up to 35 days
IL28B Genotype
Time frame: Up to 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Mitchell study director
F-star Therapeutics, Inc.
Alexander Thompson, MD, PhD principal investigator
Nucleus Network, The Alfred Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB9200 in people with Hepatitis C Infection, run by Syneos Health at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.