CClinicalTrials.gg
CompletedNCT05088174Updated Oct 21, 2021

A Trial of Hetrombopag in Healthy Subjects

A Phase 1 interventional study of Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule in Sever Aplastic Anaemia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Sep 2020, registered Oct 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sever Aplastic Anaemia

Browse trials for

03

In context

Anemia, Aplastic

343 studies on the registry are indexed under Anemia, Aplastic; 99 are open to participants now.

This study's enrollment of 26 is below the median of 39 across 268 interventional studies indexed under Anemia, Aplastic.

Browse Anemia, Aplastic studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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;
  2. Male or female subjects aged 18-55 years (inclusive);
  3. Body mass index (BMI) between 18 and 26 kg/m2 (inclusive);
  4. Normal or abnormal but not clinically significant physical examination and laboratory test results; normal or abnormal but not clinically significant ECG;
  5. 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;
  6. Able to maintain a consistency of good communication with the investigators, and understand and comply with all the requirements of this study

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. History of deep venous thrombosis or other thrombotic disorders;
  3. 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;
  4. Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody (trust), or HIV antibody;
  5. Positive pregnancy test result;
  6. Allergic constitution, or allergy to any component of hetrombopag olamine tablets and ciclosporin capsules;
  7. Have received surgery within 4 weeks before the first study administration, or plan to undergo surgery during the course of the study;
  8. Have taken any drug that alters liver enzyme activity within 28 days before the first study administration or during the study;
  9. 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;
  10. 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;
  11. 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);
  12. Have blood donation (or blood loss) of ≥ 400 mL or have received blood transfusion within 3 months before screening;
  13. Unable or unwilling to comply with the lifestyle requirements in the protocol;
  14. Addicted to smoking (≥ 5 cigarettes per day within 1 month before screening);
  15. 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;
  16. 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;
  17. Potentially unable to complete the study for other reasons or judged by the investigator as not suitable for the study.
  18. Intolerant to venipuncture, or history of hemophobia or fear of needles;
  19. Have special dietary requirements and unable to accept a standardized diet;
  20. Acute disease from screening to first study administration.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    D1:hetrombopag single dose,D11-D15:cyclosporine,D16 combination use of hetrombopag and cyclosporine

    Drug: Hetrombopag Olamine Tablet;Ciclosporin Soft Capsule

Interventions

  • DrugHetrombopag Olamine Tablet;Ciclosporin Soft Capsule

    Drug: Hetrombopag Olamine Tablet Ciclosporin Soft Capsule

06

What researchers measure

Primary outcomes

  1. Peak hetrombopag plasma concentration (Cmax)

    Time frame: 0-120 hours post dose

  2. Area Under the plasma hetrombopag concentration vs time curve (AUC0-120)

    Time frame: 0-120 hours post dose

  3. Area under the plasma hetrombopag concentration vs time curve (AUC0-inf)

    Time frame: 0-infinity

Secondary outcomes

  1. Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)

    Time frame: 0-120 hours post dose

  2. Half-life Associated With the Terminal Slope (t½)

    Time frame: 0-120 hours post dose

  3. The number of volunteers with adverse events as a measure of safety and tolerability

    Time frame: up to Day 22

07

Study locations

1 site
  • West China Second University Hospital Ethics Committee
    Chengdu, Sichuan 610041, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05088174
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Oct 21, 2021
Start date
Sep 3, 2020
Primary completion
Oct 22, 2020
Completion
Oct 22, 2020
Last update
Oct 21, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion