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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01803308




Registration number
NCT01803308
Ethics application status
Date submitted
27/02/2013
Date registered
4/03/2013
Date last updated
18/09/2019

Titles & IDs
Public title
A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
Scientific 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
Secondary ID [1] 0 0
SB12-9200-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB9200
Treatment: Drugs - SB9200
Treatment: Drugs - Placebo

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

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


Treatment: Drugs: SB9200
Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.

Treatment: Drugs: SB9200
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.

Treatment: Drugs: Placebo
Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Up to 35 days
Secondary outcome [1] 0 0
Pharmacokinetic profile of SB9200
Timepoint [1] 0 0
Up to 35 days
Secondary outcome [2] 0 0
Pharmacokinetic and Pharmacodynamic relationship of SB9200
Timepoint [2] 0 0
Up to 35 days
Secondary outcome [3] 0 0
Effect of food on exposure of SB 9200
Timepoint [3] 0 0
Up to 35 days
Secondary outcome [4] 0 0
Short Term Antiviral Efficacy
Timepoint [4] 0 0
Up to 35 days
Secondary outcome [5] 0 0
Viral Resistance
Timepoint [5] 0 0
Up to 35 days
Secondary outcome [6] 0 0
IL28B Genotype
Timepoint [6] 0 0
Up to 35 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Nucleus Network, Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Nucleus Network, The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research, The Queen Elizabeth II Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
F-star Therapeutics, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01803308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald Mitchell
Address 0 0
F-star Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries