A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject
Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
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.