Autoimmune Diseases Clinical Trial
Official 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
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.
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