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Trial details imported from

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Trial ID
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
First in Human Study of ALS-002158; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
Scientific title
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
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

Study type
Description of intervention(s) / exposure
Treatment: Drugs - ALS-002158
Treatment: Drugs - Placebo

Experimental: ALS-002158 -

Placebo Comparator: Placebo -

Treatment: Drugs: ALS-002158

Treatment: Drugs: Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
Timepoint [1] 0 0
Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
Secondary outcome [1] 0 0
Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites - Maximum measured drug concentration (Cmax), time of maximum concentration (tmax), half-life (t1/2), apparent oral clearance (CL/F), area under the concentration time curve from time zero to infinity (AUC0-inf) or area under the concentration time curve from time zero to last quantifiable concentration (AUC0-last), area under the concentration time curve during the dosing interval (AUC0-tau)
Timepoint [1] 0 0
Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
Secondary outcome [2] 0 0
HCV ribonucleic acid (RNA) viral load reduction
Timepoint [2] 0 0
Baseline to Day 31
Secondary outcome [3] 0 0
Sequence analysis of the Hepatitis C virus (HCV) NS5B region
Timepoint [3] 0 0
Baseline up to Month 6

Key inclusion criteria
- Subject has provided written consent.

- Subject is in good health as deemed by the investigator

- Creatinine clearance of greater than 50 mL/min (Cockcroft- Gault).

- Male or female, 18-55 years of age for HV and 18-65 years of age for subjects with

- Body mass index (BMI) 18-32 kg/m2 inclusive for HV and 18-36 kg/m2 for subjects with
CHC, minimum weight 50 kg in both populations.

- A female is eligible to participate in this study if she is of non-childbearing

- If male, subject is surgically sterile or practicing specific forms of birth control.

Additional inclusion criteria for subjects with CHC genotype 1 infection:

- Positive HCV antibody and a positive HCV RNA at screening.

- Documentation of CHC infection of greater than 6 months duration at screening.

- CHC genotype 1 infection at screening.

- HCV RNA viral load = 105 and = 108 IU/mL using a sensitive quantitative assay

- Liver biopsy within two years or Fibroscan evaluation within 6 months prior to
screening that clearly excludes cirrhosis. Fibroscan liver stiffness score must be <
12 kPa.

- Absence of hepatocellular carcinoma as indicated by an abdominal ultrasound scan
during screening.

- No prior treatment for CHC.

- Absence of history of clinical hepatic decompensation.

- Laboratory values include:

- prothrombin time < 1.5 × ULN.

- platelets > 120,000/mm3.

- albumin > 3.5 g/dL, bilirubin < 1.5 mg/dL at screening (subjects with documented
Gilbert's disease allowed).

- Serum ALT concentration < 5 × ULN.

- Alpha Fetoprotein (AFP) concentration = ULN. If AFP is = ULN, absence of a
hepatic mass must be demonstrated by ultrasound within the screening period.
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Clinically significant cardiovascular, respiratory, renal, gastrointestinal,
hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric

- Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab.

- Abnormal screening laboratory results that are considered clinically significant by
the investigator.

- Clinically significant drug allergy such as, but not limited to, sulfonamides and
penicillins, including those experienced in previous trials with experimental drugs.

- Participation in an investigational drug trial or having received an investigational
vaccine within 30 days or 5 half lives (whichever is longer) prior to receiving study

- Clinically significant blood loss or elective blood donation of significant volume.

- Laboratory abnormalities including:

- Thyroid Stimulating Hormone (TSH) >ULN.

- Hematocrit < 34 %.

- White blood cell counts < 3,500/mm3.

- For healthy volunteers, history of regular use of tobacco.

- The subject has a positive pre-study drug screen.

Study design
Purpose of the study
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
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
QPharm - Brisbane
Recruitment hospital [2] 0 0
CMAX - Adelaide
Recruitment hospital [3] 0 0
Linear Clinical Research Ltd - Perth
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Country [2] 0 0
New Zealand
State/province [2] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Alios Biopharma Inc.
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Vertex Pharmaceuticals Incorporated
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,
tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers
(HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.

Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will
assess food effects on pharmacokinetics in HV.

Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC
genotype 1 infection.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
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