Sever Aplastic AnaemiaPhase 1NCT05088174
A Trial of Hetrombopag in Healthy Subjects
A Phase 1 study testing Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule in people with Sever Aplastic Anaemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sever Aplastic Anaemia
- What is being tested?
- Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2020to 22 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
- Male or female subjects aged 18-55 years (inclusive);
- Body mass index (BMI) between 18 and 26 kg/m2 (inclusive);
- Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG;
- Have no plan for pregnancy and agree to take effective contraceptive measures from signing of informed consent form until 6 months after the last dose;
- Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study
Who cannot join
- Any previous or current serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease that may interfere with the results of this study;
- History of deep venous thrombosis or other thrombotic disorders;
- QTc > 450 ms in males or QTc > 460 ms in females through 12-lead ECG examination with clinical significance per the investigator's judgment at screening;
- Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody;
- Positive pregnancy test result;
- Allergic constitution, or allergy to any component of hetrombopag olamine tablets and ciclosporin capsules;
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- Have received surgery within 4 weeks before the first study administration, or plan to undergo surgery during the course of the study;
- Have taken any drug that alters liver enzyme activity within 28 days before the first study administration or during the study;
- Have taken any prescription drug, over-the-counter drug, herbal medicine, or health supplements within 14 days before the first study administration, or within 5 half-lives of the drug at screening; plan to take non-study drugs or health supplements during the study;
- Consumption of grapefruit or grapefruit-containing products, foods or beverages containing caffeine, xanthine, or alcohol within 48 h before the first study administration; strenuous exercise, or other factors that affect drug absorption, distribution, metabolism, and excretion;
- Have participated in any drug clinical trial and have been treated with any investigational drug or medical device within 3 months before the first study administration (per the date of signing the informed consent form);
- Have blood donation (or blood loss) of ≥ 400 mL or have received blood transfusion within 3 months before screening;
- Unable or unwilling to comply with the lifestyle requirements in the protocol;
- Addicted to smoking (≥ 5 cigarettes per day within 1 month before screening);
- Average daily alcohol consumption of > 15 g for females (e.g., 145 mL of wine, 497 mL of beer, or 43 mL of low-alcohol liquor) and > 25 g for males (e.g., 290 mL of wine, 994 mL of beer, or 86 mL of low-alcohol liquor) within 1 month before screening;
- History of drug abuse, history of drug dependence, or drug abuse screening positive (drugs include morphine, methamphetamine, ketamine, ecstasy (dimethylene dioxyamphetamine), and cannabis (tetrahydrocannabinol)) (consultation and examination), or history of drug abuse within the past five years or have used narcotics within 3 months before the study;
- Potentially unable to complete the study for other reasons or judged by the investigator as not suitable for the study.
- Intolerant to venipuncture, or history of hemophobia or fear of needles;
- Have special dietary requirements and unable to accept a standardized diet;
- Acute disease from screening to first study administration.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital Ethics Committee
Chengdu, Sichuan, 610041
About this study
Official title: A Single-Center, Single-Arm, Open-Label, Self-Controlled, Drug-Drug Interaction Study of Hetrombopag Olamine and Ciclosporin in Healthy Subjects
This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.
- Conditions
- Sever Aplastic Anaemia
- Being tested
- Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag Olamine Tablet；Ciclosporin Soft CapsuleDrug
Drug:
Hetrombopag Olamine Tablet Ciclosporin Soft Capsule
| Study group | Role | What they receive |
|---|---|---|
| D1：hetrombopag single dose，D11-D15：cyclosporine,D16 combination use of hetrombopag and cyclosporine | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak hetrombopag plasma concentration (Cmax)
Measured: 0-120 hours post dose
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Measured: 0-120 hours post dose
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)
Measured: 0-infinity
Secondary outcomes (3)
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Measured: 0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)
Measured: 0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start3 Sep 2020
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sever Aplastic AnaemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT05088174
- Sponsor's protocol ID
- SHR8735-111
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 21 Oct 2021
- 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 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Open-Label, Self-Controlled, Drug-Drug Interaction Study of Hetrombopag Olamine and Ciclosporin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05088174
- Acronym / sponsor ID
- SHR8735-111
- Conditions
- Sever Aplastic Anaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 21 Oct 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.
This is a single-center, single-arm, open-label, self-controlled, phase I clinical study. A total of 26 male or female healthy subjects are intended to be enrolled to evaluate the PK drug-drug interaction between ciclosporin and hetrombopag.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D1：hetrombopag single dose，D11-D15：cyclosporine,D16 combination use of hetrombopag and cyclosporine | Experimental | Drug: Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol;
- Male or female subjects aged 18-55 years (inclusive);
- Body mass index (BMI) between 18 and 26 kg/m2 (inclusive);
- Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG;
- Have no plan for pregnancy and agree to take effective contraceptive measures from signing of informed consent form until 6 months after the last dose;
Key exclusion criteria (20 listed)
- Any previous or current serious clinical conditions of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, and hematological, immunological, psychiatric and metabolic abnormalities, or any disease that may interfere with the results of this study;
- History of deep venous thrombosis or other thrombotic disorders;
- QTc > 450 ms in males or QTc > 460 ms in females through 12-lead ECG examination with clinical significance per the investigator's judgment at screening;
- Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody;
- Positive pregnancy test result;
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 |
|---|---|---|
| Hetrombopag Olamine Tablet；Ciclosporin Soft CapsuleDrug: Hetrombopag Olamine Tablet Ciclosporin Soft Capsule | Drug | D1：hetrombopag single dose，D11-D15：cyclosporine,D16 combination use of hetrombopag and cyclosporine |
Primary outcome
Peak hetrombopag plasma concentration (Cmax)
Time frame: 0-120 hours post dose
Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)
Time frame: 0-120 hours post dose
Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)
Time frame: 0-infinity
3 secondary outcomes
Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
Time frame: 0-120 hours post dose
Half-life Associated With the Terminal Slope (t½)
Time frame: 0-120 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 22
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 21 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Sever Aplastic Anaemia
RecruitingPhase 2
Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia
Sever Aplastic Anaemia, Elderly (People Aged 65 or More)
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 Hetrombopag Olamine Tablet；Ciclosporin Soft Capsule in people with Sever Aplastic Anaemia, 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 6 inclusion and 20 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 21 Oct 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?
Peak hetrombopag plasma concentration (Cmax) (time frame: 0-120 hours post dose). 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 21 Oct 2021.