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

NCT04041544 | Unknown Phase 1

• 1 other identifier: SN1011-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  From day1 of study drug dosing to day 13 for part B.

Secondary Outcomes (3)

• Pharmacokinetic Assessments of Maximum plasma concentration (Cmax)

  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)

  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)

  From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.

Study Arms (2)

SN1011

ACTIVE COMPARATOR

5 Cohort for Part A:25mg once a day,50mg once a day, 100mg once a day, 150mg once a day, 200mg once a day 4 Cohort for Part B : 50mg once a day, 100mg once a day, 200mg once a day, 100mg twice a day

Drug: SN1011

SN1011 placebo

PLACEBO COMPARATOR

5 Cohort for Part A:25mg once a day,50mg once a day, 100mg once a day, 150mg once a day, 200mg once a day 4 Cohort for Part B : 50mg once a day, 100mg once a day, 200mg once a day, 100mg twice a day

Drug: SN1011 placebo

Interventions

SN1011 DRUG

SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules.

SN1011

SN1011 placebo DRUG

The placebo to be used in this study will be identical to SN1011, minus the active ingredient.

SN1011 placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• SinoMab BioScience Ltd: lead

Study Sites (1)

Linear Clinical Research

West Perth, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Sam Salman

CONTACT

0863825100; ssalman@linear.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In each dose panel in this study, eight healthy subjects will be randomized in a 6:2 ratio to receive XNW3009 or placebo in SAD and MAD.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 23, 2019
• First Posted: August 1, 2019
• Study Start: August 27, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)