Autoimmune DiseasesPhase 1NCT04041544
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Health Subject
A Phase 1 study testing SN1011 in people with Autoimmune Diseases, run by SinoMab BioScience Ltd at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- SN1011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Aug 2019to Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Linear Clinical Research
West Perth, Western Australia, 6009
Nicola Norton, +61 8 6382 5100, contactus@linear.org.au
Sam Salman, MBBS, 0863825100 ext. 0863825100, contactus@linear.org.au
About this study
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
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.
Read the 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
- Being tested
- SN1011, SN1011 placebo
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SN1011Drug
SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules.
SN1011 placeboDrug
The placebo to be used in this study will be identical to SN1011, minus the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: SN1011 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From day1 of study drug dosing to day 13 for part B.
Secondary outcomes (3)
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)
Measured: 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)
Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration
Measured: 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)
Exposure of SN1011 will be monitored in the whole study and daily exposure calculated through area under the plasma concentration time
Measured: From day1 of study drug dosing to day4 for part A, from day1 of study drug dosing to day 13 for part B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start27 Aug 2019
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SinoMab BioScience Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041544
- Sponsor's protocol ID
- SN1011-101
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04041544
- Acronym / sponsor ID
- SN1011-101
- Conditions
- Autoimmune Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- SinoMab BioScience LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SN1011 | Active comparator | Drug: SN10115 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 |
| SN1011 placebo | Placebo comparator | Drug: SN1011 placebo5 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SN1011SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules. | Drug | SN1011 |
| SN1011 placeboThe placebo to be used in this study will be identical to SN1011, minus the active ingredient. | Drug | SN1011 placebo |
Primary outcome
Evaluate incidence and severity of adverse events
Time frame: From day1 of study drug dosing to day4 for part A.
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
Time frame: From day1 of study drug dosing to day 13 for part B.
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
Time frame: From day1 of study drug dosing to day4 for part A.
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
Time frame: From day1 of study drug dosing to day 13 for part B.
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.
3 secondary outcomes
Pharmacokinetic Assessments of Maximum plasma concentration (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.
Pharmacokinetic Assessments of Time to maximum plasma concentration (tmax)
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.
Pharmacokinetic Assessments of Area under the plasma concentration time curve (AUC)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SN1011 in people with Autoimmune Diseases, run by SinoMab BioScience Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Salman (0863825100 ext. 0863825100, ssalman@linear.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate incidence and severity of adverse events (time frame: From day1 of study drug dosing to day4 for part A.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.