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.
This study will compare SN1011 with placebo. A placebo has no active drug in it. One group of participants will take SN1011 and another group will take the placebo. The effects seen in participants taking the study drug will be compared to the effects seen in participants who are taking the placebo. This study will look at how participants react to and how the human body uses SN1011 at different dose levels. The design of the study is double-blind, randomised and placebo-controlled. In total there are planned to be 2 parts to the study. Part A will look at the effects of a single dose of the study drug and Part B will look at the effects of multiple doses of the study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules.
The placebo to be used in this study will be identical to SN1011, minus the active ingredient.
Linear Clinical Research
West Perth, Western Australia, Australia
RECRUITINGEvaluate incidence and severity of adverse events
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time frame: From day1 of study drug dosing to day4 for part A.
Evaluate incidence and severity of adverse events
An AE is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Time frame: From day1 of study drug dosing to day 13 for part B.
Evaluate clinically significant changes from baseline in physical examinations
physical examinations will be performed by a study delegated registered physician.Any findings made during the physical examination must be noted regardless of if they are part of the subject's medical history.
Time frame: From day1 of study drug dosing to day4 for part A.
Evaluate clinically significant changes from baseline in physical examinations
physical examinations will be performed by a study delegated registered physician.Any findings made during the physical examination must be noted regardless of if they are part of the subject's medical history.
Time frame: From day1 of study drug dosing to day 13 for part B.
Pharmacokinetic Assessments of Maximum plasma concentration (Cmax)
To lower the risk of volunteers in this study, exposure of SN1011 will be monitored in the whole study and daily exposure calculated through maximum plasma concentration of SN1011 (Cmax)
Time frame: From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.
Pharmacokinetic Assessments of Time to maximum plasma concentration (tmax)
Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration
Time frame: From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.
Pharmacokinetic Assessments of Area under the plasma concentration time curve (AUC)
Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration time
Time frame: From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.
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