Status:
UNKNOWN
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject
Lead Sponsor:
SinoMab BioScience Ltd
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 tis...
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 ta...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04041544
Start Date
August 27 2019
End Date
August 1 2020
Last Update
September 23 2019
Active Locations (1)
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1
Linear Clinical Research
West Perth, Western Australia, Australia, 6009