Sever Aplastic AnaemiaPhase 1NCT05088655
A Bioequivalence Study of Hetrombopag in Healthy Subjects
A Phase 1 study testing Hetrombopag Olamine Tablet in people with Sever Aplastic Anaemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Sever Aplastic Anaemia
- What is being tested?
- Hetrombopag Olamine Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to 2 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
- No healthy volunteers
- Adult
Who may be able to join
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
Who cannot join
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- History of deep vein thrombosis, or any other thromboembolic event;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
Trial locations and contacts
1 site in 1 country.
China1 site
The People's Hospital Of Liaoning Province
Shenyang, Liaoning, 110016
About this study
Official title: Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
This study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
- Conditions
- Sever Aplastic Anaemia
- Being tested
- Hetrombopag Olamine Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag Olamine TabletDrug
Hetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: T - R- R | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet |
| Treatment group B: R -T - R | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet |
| Treatment group C: R- R-T | Experimental | Not described Receives: Drug: Hetrombopag Olamine Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Measured: 0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120)
Measured: 0-120 hours post dose
area under the plasma 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 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start25 Jun 2021
- Primary completion25 Jul 2022
- Study completion2 Nov 2023
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT05088655
- Sponsor's protocol ID
- SHR8735-114
- Status last verified
- Dec 2023
- First submitted
- 12 Oct 2021
- Last updated
- 4 Dec 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Different Formulations of Hetrombopag Olamine Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05088655
- Acronym / sponsor ID
- SHR8735-114
- Conditions
- Sever Aplastic Anaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 22 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 study consists of two parts. Part 1 is a pilot BE study, and Part 2 is a pivotal study to demonstrate the bioequivalence of test and reference formulation, both of which adopt a single-center, randomized, open-label, three-period crossover design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: T - R- R | Experimental | Drug: Hetrombopag Olamine Tablet |
| Treatment group B: R -T - R | Experimental | Drug: Hetrombopag Olamine Tablet |
| Treatment group C: R- R-T | Experimental | Drug: Hetrombopag Olamine Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
- Body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);
Key exclusion criteria (5 listed)
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- History of deep vein thrombosis, or any other thromboembolic event;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
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 TabletHetrombopag Olamine Tablet (T: test formulation) Hetrombopag Olamine Tablet (R: reference formulation) | Drug | Treatment group A: T - R- R, Treatment group B: R -T - R, Treatment group C: R- R-T |
Primary outcome
Peak plasma concentration (Cmax)
Time frame: 0-120 hours post dose
Area Under the plasma concentration vs time curve (AUC0-120)
Time frame: 0-120 hours post dose
area under the plasma 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 26
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 4 Dec 2023.
- 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 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 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: finished, as of the sponsor's last update on 4 Dec 2023. 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 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 4 Dec 2023.