A Trial of CRB4101 in Healthy Subjects
Launched by CHINA RESOURCES BIOPHARMACEUTICAL CO., LTD · Nov 29, 2022
Trial Information
Current as of February 05, 2025
Unknown status
Keywords
ClinConnect Summary
The subjects who signed the informed consent form were screened by the inclusion and exclusion criteria. The subjects who met the inclusion criteria and did not meet the exclusion criteria were treated with 100 mg, 200mg, 400mg, 800 mg, 1200 mg and 1600 mg in order from low to high. In each dose group, 8 subjects will be enrolled to receive CRB4101 tablets (6 subjects) and placebo (2 subjects). In order to ensure the safety of the subjects, the sentinel method was used to enroll the subjects. Two subjects were enrolled in each dose group (1 patient received CRB4101 and 1 patient received pl...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Healthy male or female participants aged between 18 and 50 years (including 18 and 50 years) (the ratio of male/female participants to all is required to be no less than 1/3 in the groups with the dose of 200mg, 400mg and 800mg);
- • 2. Male weight in the range of 50 kg(inclusive) to 90kg, female weight in the range of 45 kg(inclusive) to 90 kg, body mass index (BMI= weight/height square (kg/㎡)) :19.0≤BMI \< 28.0;
- • 3. participant who is able to communicate well with the investigator and is willing and able to comply with all planned visits, laboratory examinations, and other study procedures.
- • 4. Have fully understood this study, voluntarily participated in the experiment, and have signed written informed consent form.
- Exclusion Criteria:
- • 1. Pregnant, lactating women, or female participants of childbearing potential who have not used contraception for at least 30 days before drug administration; Male participants who are unwilling to use contraception (or could not guarantee not to donate sperm) and female participants of childbearing potential who are unwilling to use contraception during enrollment in the trial and for 90 days after dosing;
- • 2. Suspected or definitely confirmed (inquiry) allergy to the study drug or any component in the study drug, or allergic constitution;
- • 3. participants with diseases or previous diseases (including but not limited to cardiac/cardio-cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant, hematological, immune, infectious, neurological or psychiatric diseases), surgical history or any other conditions judged by the investigator to affect the absorption, distribution, metabolism and excretion of drugs or to reduce compliance ;
- • 4. Have a personal or family history of bleeding diseases or coagulopathy, or have long-term or unexplained abnormal bleeding, such as frequent epistaxis (nosebleeds), gum bleeding, or have a high risk of bleeding such as hemorrhoids, gastrointestinal ulcers, or often have unexplained bruises/ecchymosis; participants with definite history of hemoptysis, hematemesis, melena or hematuria; Or women who are expected to be menstruating at the time of administration;
- • 5. History of cerebral hemorrhage (including congenital cerebral vascular malformations such as cerebral arteriovenous malformations or cavernous hemangiomas), stroke, and cerebrovascular accident (CVA)
- • 6. Have had risk factors for torsade de pointes, or have had a first-degree relative (i.e., biological parent, sibling, or child) family history of short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or sudden infant death in young adulthood (less than or equal to 40 years of age);
- • 7. Abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia as judged by the investigator;
- • 8. participants received anticoagulant or antiplatelet therapy within 1 month before screening; Or with adverse reactions of anticoagulant or antiplatelet drugs;
- • 9. participants with severe head trauma or major head surgery within 2 years before screening;
- • 10. Underwent major surgery within 3 months before screening or any surgery within 1 month before screening or plan to undergo surgery within 2 weeks after the end of the study;
- • 11. Individuals who has donated blood within 1 month prior to screening, or donated ≥400 mL of blood within 3 months prior to screening, or received blood or blood component transfusion within 8 weeks prior to screening and before dosing;
- • 12. Taking any prescription drugs, over-the-counter drugs or herbal medicines within 2 weeks before taking the study drug, or within 5 half-lives of the drug at the time of screening;
- • 13. Regular alcohol use in the 3 months before screening (14 units per week: 1 unit = 285 mL of beer; Or liquor 25 mL; Or wine 125 mL), or with abnormal results of alcohol breath test before enrollment;
- • 14. Smoking (≥5 cigarettes per day) or using smoking cessation products or nicotine-containing products within 2 weeks before taking the study drug; Or unable to stop using any tobacco-based products after enrollment throughout the trial;
- • 15. participants with glucose intolerance or rare genetic diseases - galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
- • 16. Consuming grapefruit/grapefruit/grapefruit, coffee, tea, and other foods or beverages containing caffeine or alcohol within 7 days before taking the study drug; Or strenuous exercise; Or have special requirements for diet, can not abide by the uniform diet;
- • 17. There are clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, fecal occult blood).
- • 18. The results of APTT, PT or INR at screening/baseline are beyond the normal range and confirmed by repeated tests;
- • 19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyltransferase (GGT) above the upper limit of normal (ULN), or total bilirubin \>ULN, or lipase or amylase \>ULN at screening/baseline visit;
- • 20. Serum creatinine \>ULN at screening/baseline visit;
- • 21. During the screening period, infectious diseases are screened for any positive of hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (anti-HCV), human immunodeficiency virus (HIV) antibody and syphilis antibody.
- • 22. Stool occult blood test is positive before randomization;
- • 23. History of drug abuse or positive urine drug screening at screening/baseline visit;
- • 24. participants who have participated in a clinical trial within 3 months before screening;
- • 25. Those who are not suitable for venous blood collection;
- • 26. Any other circumstances in which the participant are deemed by the investigator to be ineligible for the trial
About China Resources Biopharmaceutical Co., Ltd
China Resources Biopharmaceutical Co., Ltd. is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies. With a strong focus on addressing unmet medical needs, the company leverages advanced biotechnological platforms and a robust pipeline of products across various therapeutic areas, including oncology, infectious diseases, and chronic conditions. Committed to quality and efficacy, China Resources Biopharmaceutical fosters strategic collaborations and invests in cutting-edge research to enhance patient outcomes and contribute to global health advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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