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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02956850




Registration number
NCT02956850
Ethics application status
Date submitted
3/11/2016
Date registered
6/11/2016
Date last updated
5/02/2020

Titles & IDs
Public title
A Study in Healthy Volunteers and in Participants With Chronic Hepatitis B to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7020531
Scientific title
A Phase I, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Multi-Center, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of RO7020531: (1). Single and Multiple Ascending Doses in Healthy Male and Female Subjects; (2). 6-week Treatment of Patients With Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
2016-003723-38
Secondary ID [2] 0 0
NP39305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - RO7020531

Experimental: Part I: SAD in Healthy Volunteers - Healthy volunteers will receive single dose of RO7020531 or matching placebo orally on Day 1 of each cohort. A planned dose-escalation sequence for SAD is 3 milligrams (mg), 10 mg, 20 mg, 40 mg, 60 mg, 100 mg, 140 mg, and 170 mg.

Experimental: Part I: MAD in Healthy Volunteers - Healthy volunteers will receive RO7020531 (dose as selected based on safety, PK and PD data of SAD cohorts) or matching placebo orally every other day (QOD) from Day 1 through to Day 13.

Experimental: Part II: CHB Participants - CHB participants will receive RO7020531 (dose as selected based on safety, PK and PD data of MAD cohorts) or matching placebo orally QOD from Day 1 through to Day 41.


Other interventions: Placebo
Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.

Treatment: Drugs: RO7020531
RO7020531 will be administered as per schedule specified in the respective arm.

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part I: Percentage of Participants With Adverse Events
Timepoint [1] 0 0
From randomization up to Day 41
Primary outcome [2] 0 0
Part II: Percentage of Participants With Adverse Events
Timepoint [2] 0 0
From randomization up to Week 12
Secondary outcome [1] 0 0
Part I: Maximum Observed Plasma Concentration (Cmax) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [1] 0 0
SAD:Predose(0-2 hours [hrs] before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD:Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Day 1,13; Predose(0-2 hrs before dose),2,6,24 hrs postdose on Day 3,5,7,9,11
Secondary outcome [2] 0 0
Part II: Cmax of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [2] 0 0
Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21
Secondary outcome [3] 0 0
Part I: Time to Reach Cmax (Tmax) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [3] 0 0
SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11
Secondary outcome [4] 0 0
Part II: Tmax of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [4] 0 0
Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21
Secondary outcome [5] 0 0
Part I: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [5] 0 0
SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11
Secondary outcome [6] 0 0
Part II: AUCinf of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [6] 0 0
Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21
Secondary outcome [7] 0 0
Part I: Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [7] 0 0
SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11
Secondary outcome [8] 0 0
Part II: AUClast of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [8] 0 0
Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21
Secondary outcome [9] 0 0
Part I: Half-Life (t1/2) of RO7020531; and its Metabolites Including RO7011785, RO7018822 and RO7033805
Timepoint [9] 0 0
SAD: Predose(0-2 hrs before dose),0.25,0.5,1,1.5,2,3,4,6,8,12,18,24,36,48 hrs postdose. MAD: Predose (0-2 hrs before dose), 0.25,0.5,1,1.5,2,3,4,6,8,12,18,24 hrs postdose on Days 1,13; Predose (0-2 hrs before dose), 2,6,24 hrs postdose on Days 3,5,7,9,11
Secondary outcome [10] 0 0
Part II: t1/2 of RO7020531; and its Metabolites including RO7011785, RO7018822 and RO7033805
Timepoint [10] 0 0
Predose (0-2 hrs before dose), 0.25, 1, 2, 4, 6, 8, 24 hrs postdose on Days 1, 41; Predose (0-2 hrs before dose), 2-4 hrs postdose on Days 3, 7, 21
Secondary outcome [11] 0 0
Part I: Total Amount of RO7020531, RO7011785, RO7018822 and RO7033805 in Urine
Timepoint [11] 0 0
0 to 24 hrs post-dose on Day 1
Secondary outcome [12] 0 0
Part I and II: Pharmacodynamics: Plasma Neopterin Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [12] 0 0
SAD: Days 1, 2, 3, 5, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [13] 0 0
Part I and II: Pharmacodynamics: Plasma Interferon (INF)-alpha Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [13] 0 0
SAD: Days 1, 2, 3, 5, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [14] 0 0
Part I and II: Pharmacodynamics: Plasma Interferon Gamma-Inducible Protein 10 (IP-10) Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [14] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [15] 0 0
Part I and II: Pharmacodynamics: Plasma Tumor Necrosis Factor (TNF)-alpha Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [15] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [16] 0 0
Part I and II: Pharmacodynamics: Plasma IL-6 Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [16] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [17] 0 0
Part I and II: Pharmacodynamics: Plasma IL-10 Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [17] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [18] 0 0
Part I and II: Pharmacodynamics: Plasma IL-12p40 Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [18] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [19] 0 0
Part I and II: Pharmacodynamics: Peripheral Blood Interferon-Stimulated Gene (ISG) 15 messenger Ribonucleic Acid (mRNA) Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [19] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [20] 0 0
Part I and II: Pharmacodynamics: Peripheral Blood Oligoadenylate Synthetase (OAS)-1 mRNA Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [20] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [21] 0 0
Part I and II: Pharmacodynamics: Peripheral Blood Myxovirus Resistance 1 gene (MX1) mRNA Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [21] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)
Secondary outcome [22] 0 0
Part I and II: Pharmacodynamics: Peripheral blood Toll-Like Receptor (TLR) 7 mRNA Levels - SAD: Predose (0-2 hrs before dose), 2, 6, 12, 24, 48, 96 hrs postdose; Day 8. MAD: Predose (0-2 hrs before dose), 2, 6, 12, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 2, 6, 24 hrs postdose on Days 3, 5, 7, 13; Day 20. Part II: Predose (0-2 hrs before dose), 6, 8, 24 hrs postdose on Day 1; Predose (0-2 hrs before dose), 4-6, 24 hrs postdose on Days 3, 7, 21; Predose (0-2 hrs before dose), 6, 24 hrs postdose on Day 41
Timepoint [22] 0 0
SAD: Days 1, 8. MAD: Days 1, 3, 5, 7, 13, 20. Part II: Days 1, 3, 7, 21, 41 (detailed timeframe is provided in outcome measure description)

Eligibility
Key inclusion criteria
Part 1: SAD and MAD in Healthy Volunteers

- A Body Mass Index (BMI) between 18 to 32 kilograms per square meter (kg/m^2),
inclusive

- Non-smokers, or use of less than (<) 10 cigarettes (or equivalent nicotine-containing
product) per day

- Negative Anti-Nuclear Antibody (ANA) test; or positive with dilutions not greater than
1:40 and with no associated history or symptoms of potential connective tissue disease
or other immune-mediated diseases

Part 2: CHB Participants

- A BMI between 18 to 32 kg/m^2, inclusive

- CHB infection (positive test for Hepatitis B surface antigen [HBsAg] for more than 6
months prior to randomization)

- For Cohort 1, 2, 3 and 4: HBsAg detectable at screening

- For Cohort 1, 2 and 3: HBV DNA < 90 IU/mL for at least 6 months prior to
randomization; HBV DNA < 90 IU/mL at screening by Roche Cobas assay

- For Cohort 4: HBV DNA at screening >= 2 × 10*4 IU/mL for HBeAg positive and >= 2 x
10*3 IU/mL for HBeAg negative participants

- For Cohort 1, 2 and 3: Alanine amino transferase (ALT) =<1.5 × upper limit of normal
(ULN) during the 6 months prior to randomization confirmed by two measurements
separated by at least 14 days; ALT at screening =< 1.5 × ULN.

- For Cohort 4: ALT and aspartate aminotransferase (AST) at screening and Day -1 visit:
=< 5 × ULN.

- Negative ANA test; or positive with dilutions not greater than 1:40 and with no
associated history or symptoms of potential connective tissue disease or other
immune-mediated diseases

- Liver biopsy, Fibroscan® or equivalent elastography test obtained within 6 months
prior to randomization demonstrating liver disease consistent with chronic HBV
infection with absence of cirrhosis and absence of extensive bridging fibrosis
(cirrhosis or extensive bridging fibrosis are defined as greater than or equal to
(>/=) Metavir 3, recommended cut-off for Fibroscan 8.5 kilopascals [kPa])

- For Cohort 1, 2 and 3: On treatment with tenofovir, entecavir, adefovir, or
telbivudine, either as single agents or in combination, for at least 6 months

- For Cohort 4: Hepatitis B virus (HBV) treatment naïve or not on any anti-HBV treatment
for the past 6 months
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Part 1: SAD and MAD in Healthy Volunteers

- History of immunologically mediated disease (e.g., inflammatory bowel disease,
idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic
anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or
any other autoimmune disease); clinically significant psychiatric disease, acute
infection (e.g., influenza), gastrointestinal (GI) disease (including inflammatory
bowel disease, peptic ulcer disease, GI hemorrhage)

- History of having received or currently receiving any systemic anti-neoplastic
(including radiation) or immune-modulatory treatment (including systemic oral or
inhaled corticosteroids, IFN or pegylated interferon [PEG-IFN]) within the 8 weeks
prior to the first dose of study drug or the expectation that such treatment will be
needed at any time during the study

- Any clinically significant concomitant disease or condition that could interfere with,
or for which the treatment of might interfere with, the conduct of the study, or that
would, in the opinion of the Investigator, pose an unacceptable risk to the
participant in this study

- Positive Hepatitis A virus antibody (HAV Ab IgM), HBsAg, Hepatitis C antibody (HCV
Ab), or positive for human immunodeficiency virus (HIV) at screening

- History of clinically significant thyroid disease; also, participants with clinically
significant elevated thyroid-stimulating hormone (TSH) concentrations at screening

- Positive results for anti-mitochondrial antibody (AMA), anti-smooth muscle antibody
(ASMA) or thyroid peroxidase antibody

Part 2: CHB Participants

- History of liver cirrhosis

- History or other evidence of bleeding from esophageal varices

- Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or
clinical evidence such as ascites or varices)

- History or other evidence of a medical condition associated with chronic liver disease
other than HBV infection (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver
disease, toxin exposure, thalassemia, nonalcoholic steato-hepatitis, etc.). A clinical
diagnosis of fatty liver is allowed provided that non alcoholic steatohepatitis (NASH)
has been excluded by liver biopsy or non-invasive markers

- Documented history or other evidence of metabolic liver disease within one year of
randomization

- Positive test for Hepatitis A virus (IgM anti-HAV), HCV, Hepatitis D or HIV

- History of or suspicion of hepatocellular carcinoma or alpha fetoprotein >/=13
nanograms per milliliter (ng/mL) at screening

- History of immunologically mediated disease (e.g., inflammatory bowel disease,
idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic
anemia, scleroderma, severe psoriasis, rheumatoid arthritis, multiple sclerosis, or
any other autoimmune disease); clinically significant psychiatric disease, acute
infection (e.g., influenza), GI disease (including inflammatory bowel disease, peptic
ulcer disease, GI hemorrhage)

- History of having received or currently receiving any systemic anti-neoplastic
(including radiation) or immune-modulatory treatment (including systemic oral or
inhaled corticosteroids,IFN or PEG-IFN) within the 8 weeks prior to the first dose of
study drug or the expectation that such treatment will be needed at any time during
the study

- Cohort 4: Concurrent HBV treatments

- History of organ transplantation

- Clinically significant thyroid disease; also, participants with clinically significant
elevated TSH concentrations at screening

- Positive results for AMA, ASMA or thyroid peroxidase antibody

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Shatin
Country [4] 0 0
Italy
State/province [4] 0 0
Emilia-Romagna
Country [5] 0 0
Italy
State/province [5] 0 0
Lombardia
Country [6] 0 0
Netherlands
State/province [6] 0 0
Amsterdam
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
Taiwan
State/province [8] 0 0
Taichung
Country [9] 0 0
Taiwan
State/province [9] 0 0
Tainan
Country [10] 0 0
Taiwan
State/province [10] 0 0
Taipei City
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taoyuan
Country [12] 0 0
Thailand
State/province [12] 0 0
Bangkok
Country [13] 0 0
Thailand
State/province [13] 0 0
Chiang Mai
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Liverpool
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This sponsor-open, investigator- and participant-blinded, multi-center study will assess the
safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020531 in healthy
participants and in participants with chronic hepatitis B. Part I will be conducted in two
portions: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) which will include
only healthy volunteers. Part II will commence after completion of the MAD portion of Part I
and will include only Chronic Hepatitis B (CHB) participants.
Trial website
https://clinicaltrials.gov/show/NCT02956850
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: NP39305 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02956850