ThrombosisPhase 1NCT04945616
To Evaluate the Safety and Tolerability of Combined Administration of SHR2285 Tablets With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
A Phase 1 study of Thrombosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is a single-center，randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2021to 15 Jun 2022
- 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
- Healthy subjects, aged 18-55 (including boundary);
- Body mass index (BMI) between 19 to 28 kg/m2 (including boundary), male body weight ≥50 kg and <90 kg , female body weight ≥45kg and <90kg;
- Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters，etc.
- Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Who cannot join
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1.2 fold ULN during screening/baseline.
- Serum creatinine> ULN during screening/baseline.
- Positive faecal occult blood
- Abnormal coagulation function.
- A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
- Subjects with severe head trauma or head surgery within 2 years or surgery within 3 months prior to the screening.
Show all 10Show fewer
- Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
- Human immunodeficiency virus antibody, syphilis serological examination, hepatitis b virus surface antigen, hepatitis c virus antibody were positive.
- 3 months prior to screening involved in any drug or medical device clinical studies. .
- Female subjects who did not receive contraception at least 30 days before administration and etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
The study is a single-center，randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C.
- Conditions
- Thrombosis
- Being tested
- Aspirin、clopidogrel、placebo or SHR2285, Aspirin、ticagrelor、placebo or SHR2285
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin、clopidogrel、placebo or SHR2285Drug
groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；
Aspirin、clopidogrel、placebo or SHR2285Drug
groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2)
Aspirin、ticagrelor、placebo or SHR2285Drug
groupC： Aspirin + ticagrelor + placebo or SHR2285
| Study group | Role | What they receive |
|---|---|---|
| group A： Aspirin + Clopidogrel + placebo or SHR2285 (dose 1) | Experimental | Not described Receives: Drug: Aspirin、clopidogrel、placebo or SHR2285 |
| group B ：Aspirin + Clopidogrel + placebo or SHR2285 (dose 2) | Experimental | Not described Receives: Drug: Aspirin、clopidogrel、placebo or SHR2285 |
| group C： Aspirin + Ticagrelor + placebo or SHR2285 | Experimental | Not described Receives: Drug: Aspirin、ticagrelor、placebo or SHR2285 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and severity of adverse events.
Measured: from the first dose to 48hours after the last dose
Secondary outcomes (10)
Cmax
Maximum observed serum concentration (Cmax) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite steady state after multiple administrations.
Measured: from Day1 to Day8 after the first dose
Tmax
Time to maximum observed serum concentration (Tmax) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Measured: from Day1 to Day8 after the first dose
T1/2
Time to elimination half-life (T1/2) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Measured: from Day1 to Day8 after the first dose
AUC0-last
Area under the plasma concentration versus time curve (AUC0-last) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Measured: from Day1 to Day8 after the first dose
Cmax，ss
Steady-state peak concentration (Cmax，ss) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Measured: from Day1 to Day8 after the first dose
Ctrough，ss
Steady state valley concentration (Ctrough，ss) for acetylsalicylic acid and its active metabolite salicylic acid, clopidogrel, ticagrelor and its active metabolite AR-C124910XX, SHR2285 and its active metabolite at steady state after multiple administrations.
Measured: from Day1 to Day8 after the first dose
FXI activity
Clotting factor XI (FXI) activity
Measured: from Day1 to Day8 after the first dose
APTT
Change of activated partial thromboplastin time (APTT) from baseline
Measured: from Day1 to Day8 after the first dose
PT
Change of prothrombin time (PT) from baseline
Measured: from Day1 to Day8 after the first dose
INR
Change of international normalization ratio (INR) from baseline
Measured: from Day1 to Day8 after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start13 Jul 2021
- Primary completion19 Oct 2021
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945616
- Sponsor's protocol ID
- SHR2285-106
- Status last verified
- Jun 2022
- First submitted
- 1 Jun 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets Combined With Aspirin, Clopidogrel or Ticagrelor in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04945616
- Acronym / sponsor ID
- SHR2285-106
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 30 Jun 2021 (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.
The study is a single-center，randomized, doubled-blinded, placebo-controlled, Only for SHR2285 Phase I trial. This study intends to enroll 52 healthy subjects, regardless of gender. The subjects are divided into three groups: A, B, and C, with 16 cases in each of groups A and B, and 20 cases in group C.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A： Aspirin + Clopidogrel + placebo or SHR2285 (dose 1) | Experimental | Drug: Aspirin、clopidogrel、placebo or SHR2285 |
| group B ：Aspirin + Clopidogrel + placebo or SHR2285 (dose 2) | Experimental | Drug: Aspirin、clopidogrel、placebo or SHR2285 |
| group C： Aspirin + Ticagrelor + placebo or SHR2285 | Experimental | Drug: Aspirin、ticagrelor、placebo or SHR2285 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects, aged 18-55 (including boundary);
- Body mass index (BMI) between 19 to 28 kg/m2 (including boundary), male body weight ≥50 kg and <90 kg , female body weight ≥45kg and <90kg;
- Participant with no clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters，etc.
- Understand the study procedures and methods, voluntary to participate in the study and signed the informed consent.
Key exclusion criteria (10 listed)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1.2 fold ULN during screening/baseline.
- Serum creatinine> ULN during screening/baseline.
- Positive faecal occult blood
- Abnormal coagulation function.
- A clinical history of coagulation dysfunction; subjects with adverse reaction of antiplatelet drugs or anticoagulant drugs.
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 |
|---|---|---|
| Aspirin、clopidogrel、placebo or SHR2285groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ； | Drug | group A： Aspirin + Clopidogrel + placebo or SHR2285 (dose 1) |
| Aspirin、clopidogrel、placebo or SHR2285groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2) | Drug | group B ：Aspirin + Clopidogrel + placebo or SHR2285 (dose 2) |
| Aspirin、ticagrelor、placebo or SHR2285groupC： Aspirin + ticagrelor + placebo or SHR2285 | Drug | group C： Aspirin + Ticagrelor + placebo or SHR2285 |
Primary outcome
Number of subjects with adverse events and severity of adverse events.
Time frame: from the first dose to 48hours after the last dose
10 secondary outcomes
Cmax
Time frame: from Day1 to Day8 after the first dose
Tmax
Time frame: from Day1 to Day8 after the first dose
T1/2
Time frame: from Day1 to Day8 after the first dose
AUC0-last
Time frame: from Day1 to Day8 after the first dose
Cmax，ss
Time frame: from Day1 to Day8 after the first dose
Ctrough，ss
Time frame: from Day1 to Day8 after the first dose
FXI activity
Time frame: from Day1 to Day8 after the first dose
APTT
Time frame: from Day1 to Day8 after the first dose
PT
Time frame: from Day1 to Day8 after the first dose
INR
Time frame: from Day1 to Day8 after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Thrombosis
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Thrombosis, 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 10 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: finished, as of the sponsor's last update on 1 Jul 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events and severity of adverse events. (time frame: from the first dose to 48hours after the last dose). 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 1 Jul 2022.