Rheumatoid ArthritisPhase 1NCT02665910
Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients
A Phase 1 study testing SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SHR0302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects who are 18~70 years of age on the day of signing informed consent,
- Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
- Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
- Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.
Who cannot join
- Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
- Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
- Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
- Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
- Previous treatment with interferons in 4 weeks before dosing.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, 100032
Pei Hu, PhD, 86-010-69158366, pei.hu.pumc@gmail.com
Pei Hu, PhD
About this study
Official title: A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA
Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized
- Conditions
- Rheumatoid Arthritis
- Being tested
- SHR0302, SHR0302 placebo comparator
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Drug
Oral tablets (1 mg, 5 mg, 10 mg)
SHR0302 placebo comparatorDrug
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
| Study group | Role | What they receive |
|---|---|---|
| SHR0302 | Experimental | Multiple ascending doses (2, 5, 10, 25 mg), oral tablets Receives: Drug: SHR0302 |
| SHR0302 placebo comparator | Placebo comparator | Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication) Receives: Drug: SHR0302 placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and blood circulation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study
Measured: up to 48 hrs postdose
Secondary outcomes (3)
The maximum plasma concentration (Cmax) of SHR0302
Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
Measured: At protocol-specified times up to 48 hrs postdose
The area under the plasma concentration-time curve (AUC) of SHR0302
Measured: At protocol-specified times up to 48 hrs postdose
t1/2 of SHR0302
Measured: At protocol-specified times up to 48 hrs postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pei Hu, PhD, Principal investigator, Peking Union Medical College HospitalXiaofeng Zeng, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665910
- Sponsor's protocol ID
- SHR0302-102
- Status last verified
- Jan 2016
- First submitted
- 24 Jan 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA
- ClinicalTrials.gov ID
- NCT02665910
- Acronym / sponsor ID
- SHR0302-102
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR0302 | Experimental | Drug: SHR0302Multiple ascending doses (2, 5, 10, 25 mg), oral tablets |
| SHR0302 placebo comparator | Placebo comparator | Drug: SHR0302 placebo comparatorMultiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects who are 18~70 years of age on the day of signing informed consent,
- Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
- Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
- Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.
Key exclusion criteria (5 listed)
- Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
- Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
- Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
- Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
- Previous treatment with interferons in 4 weeks before dosing.
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 |
|---|---|---|
| SHR0302Oral tablets (1 mg, 5 mg, 10 mg) | Drug | SHR0302 |
| SHR0302 placebo comparatorOral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication) | Drug | SHR0302 placebo comparator |
Primary outcome
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
Time frame: up to 48 hrs postdose
Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and blood circulation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study
3 secondary outcomes
The maximum plasma concentration (Cmax) of SHR0302
Time frame: At protocol-specified times up to 48 hrs postdose
The area under the plasma concentration-time curve (AUC) of SHR0302
Time frame: At protocol-specified times up to 48 hrs postdose
t1/2 of SHR0302
Time frame: At protocol-specified times up to 48 hrs postdose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Pei Hu, PhD principal investigator
Peking Union Medical College Hospital
Xiaofeng Zeng, MD principal investigator
Peking Union Medical College Hospital
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 SHR0302 in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 4 inclusion and 5 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 19 Apr 2016. 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 China. 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 Chengyu Guan, MD (15705155015, guanchengyu@hrs.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability. (time frame: up to 48 hrs postdose). 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 19 Apr 2016.