ThrombusPhase 1NCT04229433
The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
A Phase 1 study testing SHR2285 tablet in people with Thrombus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombus
- What is being tested?
- SHR2285 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2020to 8 Nov 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males or females, aged 18-45.
- subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
- body mass index (BMI) between 18 to 28.
- Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
Who cannot join
- males or females, aged 18-45.
- subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
- body mass index (BMI) between 18 to 28.
- Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
- Serum creatinine> 1X ULN during screening/baseline.
Show all 13Show fewer
- 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.
- Blood donation or blood loss within 1 month≥200 mLor≥400 mL within 3 months before administration.
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive.
- 8.3 months prior to screening involved in any drug or medical device clinical studies or within 5 half-life of drugs before screening.
- 9.Female subjects who did not receive contraception at least 30 days before administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects
The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.
- Conditions
- Thrombus
- Being tested
- SHR2285 tablet, Placebo
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR2285 tabletDrug
Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
PlaceboDrug
Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
| Study group | Role | What they receive |
|---|---|---|
| SHR2285 | Experimental | Participants received one of 3 dose levels of SHR2285 administered as multiple oral doses. Receives: Drug: SHR2285 tablet; Drug: Placebo |
| Placebo | Experimental | Participants received one of 3 dose levels of placebo administered as multiple oral doses. Receives: Drug: SHR2285 tablet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and serious adverse events.
Measured: Pre-dose to 7 days after multiple dose administration.
Secondary outcomes (17)
PK parameter will be evaluated.
Area under the plasma concentration versus time curve (AUC) for single dose of SHR2285.
Measured: Pre-dose to 3 days after single dose administration
Maximum observed serum concentration (Cmax) for single dose of SHR2285.
Measured: Pre-dose to 3 days after single dose administration
Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.
Measured: Pre-dose to 3 days after single dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.
Measured: Pre-dose to 3 days after single dose administration.
Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285
Measured: Pre-dose to 3 days after single dose administration.
Time to elimination half-life (T1/2) for single dose of SHR2285.
Measured: Pre-dose to 3 days after single dose administration
Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration
Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration
Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration
Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration.
Time to elimination half-life (T1/2) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration
Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration.
Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration.
Accumulation ratio (Racc) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration.
Percentage of fluctuation (PTF%) for multiple dose of SHR2285.
Measured: Pre-dose to 2 days after multiple dose administration.
PD parameter will be evaluated.
FXI activity; Change of APTT, PT, INR from baseline.
Measured: Pre-dose to 3 days after single dose administration.
PD parameter will be evaluated.
FXI activity; Change of APTT, PT, INR from baseline.
Measured: Pre-dose to 2 days after multiple dose administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start11 Aug 2020
- Primary completion8 Nov 2020
- Study completion8 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombusStudies 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
- Model description
- Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 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
- NCT04229433
- Sponsor's protocol ID
- SHR2285-102
- Status last verified
- Jan 2020
- First submitted
- 18 Dec 2019
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- 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 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single -Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04229433
- Acronym / sponsor ID
- SHR2285-102
- Conditions
- Thrombus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 8 Nov 2020 (actual)
- Study completion
- 8 Nov 2020 (actual)
- First posted
- 18 Jan 2020 (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 randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered single dose and multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
| Arm | Type | Receives |
|---|---|---|
| SHR2285 | Experimental | Drug: SHR2285 tablet, Drug: PlaceboParticipants received one of 3 dose levels of SHR2285 administered as multiple oral doses. |
| Placebo | Experimental | Drug: SHR2285 tablet, Drug: PlaceboParticipants received one of 3 dose levels of placebo administered as multiple oral doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males or females, aged 18-45.
- subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
- body mass index (BMI) between 18 to 28.
- Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
Key exclusion criteria (13 listed)
- males or females, aged 18-45.
- subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP<140mmHg; 50mmHg ≤DBP<90mmHg and 50 ≤ HR <110 beats / min.
- body mass index (BMI) between 18 to 28.
- Participant in general good health. No clinically significant findings in vital signs, physical examination, 12-lead ECG ,X-ray and laboratory parameters.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin/direct bilirubin > 1X ULN during screening/baseline.
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 |
|---|---|---|
| SHR2285 tabletPharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses. | Drug | Placebo, SHR2285 |
| PlaceboPharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses. | Drug | Placebo, SHR2285 |
Primary outcome
Number of subjects with adverse events and serious adverse events.
Time frame: Pre-dose to 7 days after multiple dose administration.
17 secondary outcomes
PK parameter will be evaluated.
Time frame: Pre-dose to 3 days after single dose administration
Maximum observed serum concentration (Cmax) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Time to maximum observed serum concentration (Tmax) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Apparent total clearance of the drug from plasma after oral administration (CL/F) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration.
Apparent volume of distribution after non-intravenous administration (V/F) for single dose of SHR2285
Time frame: Pre-dose to 3 days after single dose administration.
Time to elimination half-life (T1/2) for single dose of SHR2285.
Time frame: Pre-dose to 3 days after single dose administration
Area under the plasma concentration versus time curve (AUC) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Steady-state peak concentration (Cmax，ss) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Steady state valley concentration (Ctrough，ss) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Time to maximum observed serum concentration (Tmax) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Time to elimination half-life (T1/2) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration
Steady-state apparent total clearance of the drug from plasma after oral administration (CLSS/F) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Steady-state apparent volume of distribution after non-intravenous administration (VSS/F) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Accumulation ratio (Racc) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
Percentage of fluctuation (PTF%) for multiple dose of SHR2285.
Time frame: Pre-dose to 2 days after multiple dose administration.
PD parameter will be evaluated.
Time frame: Pre-dose to 3 days after single dose administration.
PD parameter will be evaluated.
Time frame: Pre-dose to 2 days after multiple dose administration.
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 25 May 2021.
- 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.
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 testing SHR2285 tablet in people with Thrombus, 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 13 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 25 May 2021. 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 serious adverse events. (time frame: Pre-dose to 7 days after multiple dose administration.). 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 25 May 2021.