NCT04041544

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: SinoMab BioScience Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	SN1011	SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules.
DRUG	SN1011 placebo	The placebo to be used in this study will be identical to SN1011, minus the active ingredient.

Timeline

• Start date: 2019-08-27
• Primary completion: 2020-07-01
• Completion: 2020-08-01
• First posted: 2019-08-01
• Last updated: 2019-09-23

Locations

1 site across 1 country: Australia