Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05592262
Other study ID # SHR2554-I-109
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 15, 2022
Est. completion date December 14, 2022

Study information

Verified date December 2022
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of SHR2554 Tablets in healthy subjects.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 14, 2022
Est. primary completion date December 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent; 2. Body weight = 50.0 kg for men and body weight = 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 26.0 kg /m2 (inclusive); 3. The mean value of three 12-lead ECG tests was normal or abnormal but not clinically significant, the time limit from Q wave to T wave was < 430 msec for male (QTcF), and < 450 msec for female (QTcF), and the heart rate was in the normal range or abnormal but not clinically significant. 4. Creatinine clearance (CLCr) =80 mL/min, and creatinine is less than or equal to the upper limit of normal value; 5. Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening; 6. Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study. Exclusion Criteria: 1. Patients with abnormal vital signs (systolic blood pressure <90 mmHg or >140 mmHg, diastolic blood pressure <50 mmHg or >90 mmHg) or abnormal physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and other tests with clinical significance; 2. Abnormal X-ray examination with clinical significance; 3. Hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody are positive or HIV antibody is not negative; 4. Allergic constitution, including history of severe drug allergy or drug allergy; Allergic history to SHR2554 tablets or the excipients thereof; 5. Previous history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.; 6. Lung diseases, including invasive lung disease, pneumonia, dyspnea, etc.; 7. History of chronic kidney disease, renal insufficiency, and renal anemia; 8. History of dysphagia or any gastrointestinal disease that affects drug absorption; 9. Any uncontrolled peptic ulcer, colitis, pancreatitis, etc.; 10. Other important organs of primary diseases, such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and clear history of musculoskeletal system including but not limited to tumor patient or a history of cancer, such as not good control of diabetes, high blood pressure, etc.), the researchers think that don't fit for the researchers; 11. Patients who had undergone any surgery that would affect drug absorption, distribution, metabolism, or excretion within 3 months prior to screening; 12. Took hepatotoxic drugs (e.g. Dapsone, erythromycin, fluconazole, ketoconazole, rifampin) within 6 months before screening; 13. Candidates who participated in clinical trials within 3 months before screening; 14. Took any drug that alters the activity of liver enzymes within 28 days prior to taking the study drug; 15. Took any prescription or over-the-counter medications in the 7 days prior to taking the study drug; 16. Took any vitamin products or herbs in the 7 days prior to taking the study drug; 17. History of substance abuse, drug use and/or alcohol abuse: a history of substance abuse in the 6 months prior to screening, or a positive urine substance abuse screening test in the screening/baseline period, or drug use in the 3 months prior to screening; Heavy drinkers (14 units of alcohol per week: 1 unit = 285mL beer, 25mL liquor, or 100mL wine; Smoking =5 cigarettes per day), or having a positive alcohol breath test during the screening period/baseline, or being unable to smoke or abstain during the trial; 18. Drinking grapefruit juice, beverages containing xanthine, caffeine, alcohol, strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion within 48 hours before taking the study drug; 19. Participants who donated blood =400 mL or lost blood =400 mL within 3 months before screening, or received blood transfusion; 20. Patients with a history of needle sickness and blood sickness have difficulty in blood collection or cannot tolerate venipuncture blood collection; 21. Other factors considered by the investigator to be inappropriate for trial participation.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHR2554
On an empty stomach - after meals
SHR2554
After meals - on an empty stomach

Locations

Country Name City State
China Zhongshan Hospital Affiliated to Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameters of SHR2554: Cmax day 1 to day 10
Primary Pharmacokinetic parameters of SHR2554: AUC0-t day 1 to day 10
Primary Pharmacokinetic parameters of SHR2554: AUC0-8 (if applicable) day 1 to day 10
Secondary Pharmacokinetic parameters of SHR2554: Tmax day 1 to day 10
Secondary Pharmacokinetic parameters of SHR2554: t1/2 day 1 to day 10
Secondary Pharmacokinetic parameters of SHR2554: CL/F day 1 to day 10
Secondary Pharmacokinetic parameters of SHR2554: Vz/F day 1 to day 10
Secondary The incidence and severity of adverse events/serious adverse events. from ICF signing date to approximate day 17
See also
  Status Clinical Trial Phase
Recruiting NCT04691349 - CAR-T for r/r Malignant Tumors in Children Early Phase 1
Recruiting NCT04672473 - Treatment of Malignant Tumors With Antigen Peptide-specific DC-CTL Cells and Decitabine Phase 1/Phase 2
Recruiting NCT06080984 - The Application of Novel Oncolytic Virus in Late Stage Solid Tumors Phase 1
Recruiting NCT04991506 - A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors Phase 1
Completed NCT02552004 - Assessment of Intraoperative Probe-based Confocal Laser Endomicroscopy in Digestive and Endocrine Surgery: a Pilot Study N/A
Recruiting NCT05280873 - Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP Phase 1
Completed NCT06093945 - Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects Phase 1
Completed NCT03012945 - Epidural Anesthesia-analgesia and Long-term Outcome N/A
Recruiting NCT04686682 - A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors Phase 1/Phase 2
Recruiting NCT06084767 - 68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer N/A
Enrolling by invitation NCT02937246 - Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction N/A
Completed NCT03354741 - Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children N/A
Recruiting NCT03931720 - Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor Phase 1/Phase 2
Completed NCT01906632 - Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy N/A
Recruiting NCT05596344 - Long-term Follow-up of Anxiety and Depression in Patients With Malignant Tumors
Active, not recruiting NCT04230200 - Prospective Screening Programme for Malignant Tumors
Completed NCT04952766 - Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults Phase 4
Completed NCT04730843 - A Study of ES102 (OX40 Agonist) in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT05781555 - A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors N/A
Completed NCT01884168 - Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy