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

Primary Purpose

Autoimmune Diseases

Status

Unknown status

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

SN1011

SN1011 placebo

About this trial

This is an interventional treatment trial for Autoimmune Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Linear Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SN1011

SN1011 placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

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.

Evaluate clinically significant changes from baseline in physical examinations

Secondary Outcome Measures

Pharmacokinetic Assessments of Maximum plasma concentration (Cmax)

To lower the risk of volunteers in this study, exposure of SN1011 will be monitored in the whole study and daily exposure calculated through maximum plasma concentration of SN1011 (Cmax)

Pharmacokinetic Assessments of Time to maximum plasma concentration (tmax)

Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration

Pharmacokinetic Assessments of Area under the plasma concentration time curve (AUC)

Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration time

Full Information

NCT ID

NCT04041544

First Posted

July 23, 2019

Last Updated

September 19, 2019

Sponsor

SinoMab BioScience Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04041544

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 27, 2019 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SinoMab BioScience Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SN1011

Arm Type

Active Comparator

Arm Description

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

Arm Title

SN1011 placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SN1011

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SN1011 placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Evaluate incidence and severity of adverse events

Description

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.

Time Frame

From day1 of study drug dosing to day4 for part A.

Title

Evaluate incidence and severity of adverse events

Description

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.

Time Frame

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

Title

Evaluate clinically significant changes from baseline in physical examinations

Description

Time Frame

From day1 of study drug dosing to day4 for part A.

Title

Evaluate clinically significant changes from baseline in physical examinations

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Pharmacokinetic Assessments of Maximum plasma concentration (Cmax)

Description

To lower the risk of volunteers in this study, exposure of SN1011 will be monitored in the whole study and daily exposure calculated through maximum plasma concentration of SN1011 (Cmax)

Time Frame

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

Title

Pharmacokinetic Assessments of Time to maximum plasma concentration (tmax)

Description

Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration

Time Frame

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

Title

Pharmacokinetic Assessments of Area under the plasma concentration time curve (AUC)

Description

Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration time

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sam Salman

Phone

0863825100

Ext

0863825100

ssalman@linear.org.au

Facility Information:

Facility Name

Linear Clinical Research

City

West Perth

State/Province

West Australia

ZIP/Postal Code

6009

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicola Norton

Phone

+61 8 6382 5100

contactus@linear.org.au

First Name & Middle Initial & Last Name & Degree

Sam Salman, MBBS

Phone

0863825100

Ext

0863825100

contactus@linear.org.au

First Name & Middle Initial & Last Name & Degree

Sam Salman, MBBS

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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