Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Adult Patients With Chronic Primary ITP; Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy
• Intervention / Treatment: Drug: Herombopag Olamine Tablets

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hongda Lin; Phone Number: +86-0518-82342973; Email: hongda.lin@hengrui.com
• Study Contact Backup: Name: Sheng Feng; Phone Number: +86-0518-82342973; Email: sheng.feng@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Male or female aged 18-45 at screening (both inclusive)
3. Body mass index (BMI) at 19.0~28.0 kg/m2 (including critical value)
4. 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
5. 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

Exclusion Criteria:

1. 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;.
2. People with a history of deep vein thrombosis or other thrombotic disorders.
3. 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)。
4. Those who test positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody
5. Those with a positive pregnancy test.
6. 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.
7. Those who had undergone surgery within 4 weeks prior to screening, or who planned to undergo surgery during the study.
8. Has taken any prescription, over-the-counter, herbal or health product within 14 days prior to screening or dosing.
9. Those who participated in any clinical trial and used any investigational drug within 3 months prior to screening.
10. Blood donation (or blood loss) and blood donation (or blood loss) ≥400 mL within 3 months before screening, or receiving blood transfusion
11. Those who have special dietary requirements and cannot comply with the diet and corresponding regulations provided by the test.
12. 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.
13. 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.
14. Positive alcohol test.
15. Those who have a history of drug abuse, drug dependence or positive urine drug screening within 3 months prior to screening.
16. Patients with a history of needle fainting or blood fainting, or those who cannot tolerate venous puncture blood collection.
17. People with difficulty swallowing tablets
18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; 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;	Drug: Herombopag Olamine Tablets; Three Herombopag Olamine Tablets is administered to healthy subjects.
Experimental: Treatment group B; 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	Drug: Herombopag Olamine Tablets; Three Herombopag Olamine Tablets is administered to healthy subjects.
Experimental: Treatment group C; 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	Drug: Herombopag Olamine Tablets; Three Herombopag Olamine Tablets is administered to healthy subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PK parameters：Cmax	0hour to 120hours after the last dosing
PK parameters：AUC0-t	0hour to 120hours after the last dosing
PK parameters：AUC0-∞	0hour to 120hours after the last dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameters：Tmax	0hour to 120hours after the last dosing
PK parameters：t1/2	0hour to 120hours after the last dosing
PK parameters：CL/F	0hour to 120hours after the last dosing
PK parameters：V/F	0hour to 120hours after the last dosing
Incidence and severity of adverse events (AEs)	from screening to 120 hours after the last dosing

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): November 15, 2023

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHR8735-115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No