Adult Patients With Chronic Primary ITPPhase 1NCT06062680
Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects
A Phase 1 study testing Herombopag Olamine Tablets in people with Adult Patients With Chronic Primary ITP and Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This study used a single-center, randomized, open-label, three-period, crossover trial design. Fifteen healthy subjects were planned to be enrolled, and the subjects were randomly assigned to any group A, B and C in the order of screening, with 5 cases in each group Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Patients With Chronic Primary ITP, Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
- What is being tested?
- Herombopag Olamine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to 15 Nov 2023
- 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
- Able and willing to provide a written informed consent
- Male or female aged 18-45 at screening (both inclusive)
- Body mass index (BMI) at 19.0~28.0 kg/m2 (including critical value)
- Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from 2 weeks before screening to 3 months after the last administration of the study drug, and ensure the use of one or more contraceptive methods during sexual life during this period
Who cannot join
- People who have or are currently suffering from any clinically serious medical conditions such as circulatory, endocrine, neurological, digestive, respiratory, hematology, immunological, psychiatric and metabolic abnormalities within the previous year or any other disease that can interfere with the test results;.
- People with a history of deep vein thrombosis or other thrombotic disorders.
- Prolonged QTcF on 12-ECG at screening (450 ms > men and >470 ms) (corrected for Fridericia's formula or other clinically significant abnormalities determined by the clinician)。
- Those who test positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody
- Those with a positive pregnancy test.
- Allergies, such as those with a known history of allergy to two or more substances; or anyone allergic to Hydrazopag Ethanolamine tablets and their excipients.
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- Those who had undergone surgery within 4 weeks prior to screening, or who planned to undergo surgery during the study.
- Has taken any prescription, over-the-counter, herbal or health product within 14 days prior to screening or dosing.
- Those who participated in any clinical trial and used any investigational drug within 3 months prior to screening.
- Blood donation (or blood loss) and blood donation (or blood loss) ≥400 mL within 3 months before screening, or receiving blood transfusion
- Those who have special dietary requirements and cannot comply with the diet and corresponding regulations provided by the test.
- Those who smoked an average of 5 or more cigarettes per day in the month prior to screening or could not stop using any tobacco products during the test period.
- Those who consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ≈360mL beer or 45mL spirits with 40% alcohol content or 150mL wine) in the three months before screening, or who could not abrol during the test period.
- Positive alcohol test.
- Those who have a history of drug abuse, drug dependence or positive urine drug screening within 3 months prior to screening.
- Patients with a history of needle fainting or blood fainting, or those who cannot tolerate venous puncture blood collection.
- People with difficulty swallowing tablets
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Trial of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects
This study used a single-center, randomized, open-label, three-period, crossover trial design. Fifteen healthy subjects were planned to be enrolled, and the subjects were randomly assigned to any group A, B and C in the order of screening, with 5 cases in each group
- Conditions
- Adult Patients With Chronic Primary ITP, Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
- Being tested
- Herombopag Olamine Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herombopag Olamine TabletsDrug
Three Herombopag Olamine Tablets is administered to healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Take Herombopag Olamine Tablets 7.5mg 4h after high-fat meal in the first cycle, and take Herombopag Olamine Tablets 7.5mg on an empty stomach in the second cycle. In the third cycle, take Herombopag Olamine Tablets 7.5mg 30min after a standard meal; Receives: Drug: Herombopag Olamine Tablets |
| Treatment group B | Experimental | Take Herombopag Olamine Tablets 7.5mg on an empty stomach in the first cycle, and take Herombopag Olamine Tablets 7.5mg 30min after a standard meal in the second cycle. In the third cycle, Herombopag Olamine Tablets 7.5mg were taken 4h after a high-fat meal Receives: Drug: Herombopag Olamine Tablets |
| Treatment group C | Experimental | Take Herombopag Olamine Tablets 7.5mg 30min after standard meal in the first cycle, and take Herombopag Olamine Tablets 7.5mg 4h after high-fat meal in the second cycle. In the third cycle, Herombopag Olamine Tablets 7.5mg were taken on an empty stomach Receives: Drug: Herombopag Olamine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters：Cmax
Measured: 0hour to 120hours after the last dosing
PK parameters：AUC0-t
Measured: 0hour to 120hours after the last dosing
PK parameters：AUC0-∞
Measured: 0hour to 120hours after the last dosing
Secondary outcomes (5)
PK parameters：Tmax
Measured: 0hour to 120hours after the last dosing
PK parameters：t1/2
Measured: 0hour to 120hours after the last dosing
PK parameters：CL/F
Measured: 0hour to 120hours after the last dosing
PK parameters：V/F
Measured: 0hour to 120hours after the last dosing
Incidence and severity of adverse events (AEs)
Measured: from screening to 120 hours after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients With Chronic Primary ITPStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
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
- NCT06062680
- Sponsor's protocol ID
- SHR8735-115
- Status last verified
- Aug 2023
- First submitted
- 1 Sep 2023
- Last updated
- 2 Oct 2023
- 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06062680
- Acronym / sponsor ID
- SHR8735-115
- Conditions
- Adult Patients With Chronic Primary ITP, Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 2 Oct 2023 (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.
This study used a single-center, randomized, open-label, three-period, crossover trial design. Fifteen healthy subjects were planned to be enrolled, and the subjects were randomly assigned to any group A, B and C in the order of screening, with 5 cases in each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: Herombopag Olamine TabletsTake Herombopag Olamine Tablets 7.5mg 4h after high-fat meal in the first cycle, and take Herombopag Olamine Tablets 7.5mg on an empty stomach in the second cycle. In the third cycle, take Herombopag Olamine Tablets 7.5mg 30min after a standard meal; |
| Treatment group B | Experimental | Drug: Herombopag Olamine TabletsTake Herombopag Olamine Tablets 7.5mg on an empty stomach in the first cycle, and take Herombopag Olamine Tablets 7.5mg 30min after a standard meal in the second cycle. In the third cycle, Herombopag Olamine Tablets 7.5mg were taken 4h after a high-fat meal |
| Treatment group C | Experimental | Drug: Herombopag Olamine TabletsTake Herombopag Olamine Tablets 7.5mg 30min after standard meal in the first cycle, and take Herombopag Olamine Tablets 7.5mg 4h after high-fat meal in the second cycle. In the third cycle, Herombopag Olamine Tablets 7.5mg were taken on an empty stomach |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent
- Male or female aged 18-45 at screening (both inclusive)
- Body mass index (BMI) at 19.0~28.0 kg/m2 (including critical value)
- Subjects who are considered to be generally healthy, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Subjects (including male subjects) are willing to have no birth plan and voluntarily adopt effective contraceptive measures and no sperm donation plan from 2 weeks before screening to 3 months after the last administration of the study drug, and ensure the use of one or more contraceptive methods during sexual life during this period
Key exclusion criteria (18 listed)
- People who have or are currently suffering from any clinically serious medical conditions such as circulatory, endocrine, neurological, digestive, respiratory, hematology, immunological, psychiatric and metabolic abnormalities within the previous year or any other disease that can interfere with the test results;.
- People with a history of deep vein thrombosis or other thrombotic disorders.
- Prolonged QTcF on 12-ECG at screening (450 ms > men and >470 ms) (corrected for Fridericia's formula or other clinically significant abnormalities determined by the clinician)。
- Those who test positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody
- Those with a positive pregnancy test.
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 |
|---|---|---|
| Herombopag Olamine TabletsThree Herombopag Olamine Tablets is administered to healthy subjects. | Drug | Treatment group A, Treatment group B, Treatment group C |
Primary outcome
PK parameters：Cmax
Time frame: 0hour to 120hours after the last dosing
PK parameters：AUC0-t
Time frame: 0hour to 120hours after the last dosing
PK parameters：AUC0-∞
Time frame: 0hour to 120hours after the last dosing
5 secondary outcomes
PK parameters：Tmax
Time frame: 0hour to 120hours after the last dosing
PK parameters：t1/2
Time frame: 0hour to 120hours after the last dosing
PK parameters：CL/F
Time frame: 0hour to 120hours after the last dosing
PK parameters：V/F
Time frame: 0hour to 120hours after the last dosing
Incidence and severity of adverse events (AEs)
Time frame: from screening to 120 hours after the last dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Herombopag Olamine Tablets in people with Adult Patients With Chronic Primary ITP and Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy, run by Jiangsu HengRui Medicine Co., Ltd..
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 5 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 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Feng (+86-0518-82342973, sheng.feng@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters：Cmax (time frame: 0hour to 120hours after the last dosing). The study lists 3 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 2 Oct 2023.