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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/NCT04041544




Registration number
NCT04041544
Ethics application status
Date submitted
23/07/2019
Date registered
1/08/2019
Date last updated
23/09/2019

Titles & IDs
Public title
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SN1011 Following Single and Multiple Oral Dose Administration
Secondary ID [1] 0 0
SN1011-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SN1011
Treatment: Drugs - SN1011 placebo

Active Comparator: SN1011 - 5 Cohort for Part A:25mg once a day,50mg once a day, 100mg once a day, 150mg once a day, 200mg once a day 4 Cohort for Part B : 50mg once a day, 100mg once a day, 200mg once a day, 100mg twice a day

Placebo Comparator: SN1011 placebo - 5 Cohort for Part A:25mg once a day,50mg once a day, 100mg once a day, 150mg once a day, 200mg once a day 4 Cohort for Part B : 50mg once a day, 100mg once a day, 200mg once a day, 100mg twice a day


Treatment: Drugs: SN1011
SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules.

Treatment: Drugs: SN1011 placebo
The placebo to be used in this study will be identical to SN1011, minus the active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate incidence and severity of adverse events
Timepoint [1] 0 0
From day1 of study drug dosing to day4 for part A.
Primary outcome [2] 0 0
Evaluate incidence and severity of adverse events
Timepoint [2] 0 0
From day1 of study drug dosing to day 13 for part B.
Primary outcome [3] 0 0
Evaluate clinically significant changes from baseline in physical examinations
Timepoint [3] 0 0
From day1 of study drug dosing to day4 for part A.
Primary outcome [4] 0 0
Evaluate clinically significant changes from baseline in physical examinations
Timepoint [4] 0 0
From day1 of study drug dosing to day 13 for part B.
Secondary outcome [1] 0 0
Pharmacokinetic Assessments of Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.
Secondary outcome [2] 0 0
Pharmacokinetic Assessments of Time to maximum plasma concentration (tmax)
Timepoint [2] 0 0
From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.
Secondary outcome [3] 0 0
Pharmacokinetic Assessments of Area under the plasma concentration time curve (AUC)
Timepoint [3] 0 0
From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.

Eligibility
Key inclusion criteria
- Able to give signed written informed consent form

- Body mass index (weight [kg]/height [m]2) within 18.0 to 30.0 kg/m2 (inclusive);

- Blood pressure < 140/90 mmHg at screening and heart rate <100 bpm. One repeat
assessment is permitted;

- No clinically significant abnormalities in the 12-lead ECG.

- Creatinine clearance = 90 mL/min at screening;

- Overtly healthy as determined by medical evaluation including medical history and
physical examination at screening;

- Have clinical laboratory test results within the study site's normal reference range
for: absolute neutrophil count, potassium, liver and kidney function tests. No other
screening clinically significant abnormal laboratory tests results. Two repeat
assessments are permitted at the discretion of the investigator;

- If male, be willing to remain abstinent

- If female, be of non-childbearing potentia.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of severe drug or excipient allergy, or hypersensitivity to SN1011 capsules or
other BTK inhibitors;

- History of stomach or intestinal surgery or resection

- Current or chronic history of liver disease or known hepatic or biliary abnormalities;

- Current or history of cardiac arrythmias;

- Recent or current serious infection;

- Have had symptomatic herpes zoster infection within 12 weeks of screening;

- Current or history autoimmune disease, or suspected autoimmune disease;

- Presence of cataract(s) or prior history of cataract surgery;

- Recent administration or plans to receive administration of live vaccine;

- Major illness or surgery (except for minor outpatient surgery) within 3 months of
study Day 1, or planned surgery during study;

- Intolerance to direct venipuncture;

- Known or suspected history of drug abuse within the past 2 years

- Participation in any clinical study with an investigational drug, biologic or device
within 4 weeks;

- Positive screening test for serum hepatitis B surface antigen, hepatitis C antibody or
human immunodeficiency virus (HIV);

- Malignancy within 5 years of screening visit (excluding non-melanoma skin cancer that
has been resected);

- Evidence of active or latent tuberculosis (TB);

- Pregnant or lactating women;

- Subject who is considered unsuitable for participating in the study in the opinion of
investigator.

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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/08/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2020
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
West Australi
Recruitment hospital [1] 0 0
Linear Clinical Research - West Perth
Recruitment postcode(s) [1] 0 0
6009 - West Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SinoMab BioScience Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
SN1011 (the study drug), is currently being developed by Sinomab as a new drug for treating
autoimmune disease (diseases occurring when your body's natural immune/defence mechanism
attacks healthy tissue and nerves), such as rheumatoid arthritis (RA). RA causes recurrent
joint pain and swelling, particularly in the hands and feet, and can lead to bone erosion and
joint deformity.

SN1011 is known as a BTK inhibitor. Bruton's tyrosine kinase (BTK) is an enzyme that plays a
key role in B-cell development, and B-cells play an important role in immunity throughout the
body. It is thought that blocking the BTK signal may inhibit disease progression in people
with RA and may even resolve the disease.

The purpose of this research study is to assess the safety and tolerability of SN1011 as well
as the pharmacokinetics (PK - how your body handles the study drug) and pharmacodynamics (PD
- how the study drug affects your body) of the study drug. The investigators are doing this
study in healthy men and women.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04041544
Trial related presentations / publications
Public notes

Contacts
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
Sam Salman
Address 0 0
Country 0 0
Phone 0 0
0863825100
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04041544