Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04820049
Other study ID # GNI-F573-202001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 8, 2021
Est. completion date November 6, 2022

Study information

Verified date March 2021
Source Beijing Continent Pharmaceutical Co, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Tolerance and PK study of F573


Description:

The tolerance and PK study of single dose and multi dose F573.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 6, 2022
Est. primary completion date August 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion criteria (each item must be met) 1. Healthy volunteers, male and female; 2. Age: 18-45 years old; 3. Weight: male =50kg, female =45kg, 19=BMI=26 (BMI= weight (kg)/height 2 (m2)); 4. Passed the comprehensive physical examination, that is, the routine blood and urine, blood pregnancy, blood glucose, blood lipids, blood electrolytes, hepatitis B surface antigen, liver and kidney function, hepatitis C, HIV and syphilis antibody test, electrocardiogram, cigarette test, urine drug screening, alcohol breath test, chest X-ray and other abnormal or abnormal without clinical significance; 5. Have a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial before the study, and voluntarily participate in the clinical trial, be able to communicate well with the researchers, comply with the requirements of the whole study, and have the ability to understand and sign the written informed consent. Exclusion criteria (if one of them is met) 1. Participated in any other clinical trials within the three months prior to the trial; 2. (preliminary) of any process may affect test security, or drug in the body of the disease, including but not limited to: heart, liver, kidney, endocrine, the digestive tract, immune system and respiratory system always or the existing system diseases (especially cardiovascular diseases including cardiovascular disease risk, any impact on drug absorption of gastrointestinal diseases (such as irritable bowel syndrome, inflammatory bowel disease), active pathological bleeding (such as peptic ulcer), urticaria, eczema, dermatitis, epilepsy, allergic rhinitis, asthma, etc.); 3. (Inquiry) Allergic constitution: if there is a history of drug, food allergy or skin allergy; 4. (Inquiry) Use of any drug that inhibits or induces liver metabolism to the drug within 28 days prior to use of the study drug (Common liver enzyme inducers: barbiturates such as phenobarbital, carbamazepine, aminomide, griseofulvin, metalpropanol, phenytoin, glumide, rifampicin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamides); 5. Have used any medicine (including Chinese herbal medicine) and health care products within 14 days before the first administration; 6. (Consultation) People who have special requirements for food and cannot abide by the unified diet (such as intolerance to standard food); 7. (consultation) can not tolerate venipuncture, intramuscular injection and/or have a history of dizziness of blood and needles; 8. (Consultation) Drinking excessively tea, coffee or caffeinated beverages for a long time in the past (more than 8 cups a day, 1 cup =250mL); Or study within 48 hours before the first administration of the drug, the intake of any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) and other special diet that affects the absorption, distribution, metabolism, excretion of the drug; 9. (Inquiry) Previous alcohol abuse (i.e., more than 28 SUs per week for men and more than 21 SUs per week for women (1 SU contains 14 g of alcohol, such as 360 mL beer or 45 mL 40% spirits or 150 mL wine); Or regular alcohol consumption (more than 14 standard units per week) in the 6 months prior to the study; Or have taken any alcoholic product within 24 hours prior to first administration; 10. (Inquiry) who donated blood or suffered massive bleeding (greater than 450 mL) within 3 months before the first administration of the study, or who planned to donate blood or blood components during the study or within 3 months after the end of the study; 11. (Inquiry) Acute disease occurs in the pre-study screening stage or before the study medication; 12. (Inquiry) Those who took food or beverage (such as grapefruit, mango, dragon fruit, grape juice, orange juice and other rich flavonoids or citrus compounds) containing enzymes that can induce or inhibit liver metabolism within 24 hours before the first administration of medication; 13. (Consultation) had surgery within 3 months prior to the screening period, or planned to have surgery during the study period; 14. (Inquiry) Previous history of drug abuse; With a history of drug abuse; 15. Smoking more than 5 cigarettes per day in the 14 days before screening, or unable to stop using any tobacco products during the trial; 16. Screening (Consultation) Those who smoked or used any tobacco products during the admission period; 17. Positive results of nicotine test; 18. Alcohol breath test with test results greater than 0.0mg/100mL; 19. Positive urine drug screening; 20. Pregnant or lactating women; 21. Those who had family planning during the study period and within 6 months after the end of the study; 22. Refusing to use non-drug contraception during the study period 23. novel coronavirus nucleic acid test positive or antibody test positive; 24. The investigator considers that there is any circumstance that may affect the subject's ability to give informed consent or follow the study protocol, or that the participant's participation in the study may affect the study result or their own safety.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
F573
F573 for injection
Other:
Placebo
Water for injection

Locations

Country Name City State
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Beijing Continent Pharmaceutical Co, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary MTD of F573 in health people up to 7 days
Primary Cmax of F573 in health people up to 7 days
Primary Tmax of F573 in health people up to 7 days
Primary t1/2 of F573 in health people up to 7 days
Primary AUC of F573 in health people up to 7 days
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 8 days
See also
  Status Clinical Trial Phase
Completed NCT05592951 - Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers N/A
Completed NCT04689035 - A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144 Phase 1
Recruiting NCT02129296 - Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study Phase 1/Phase 2
Completed NCT06114524 - Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation N/A
Active, not recruiting NCT06286488 - Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza Phase 4
Completed NCT04529759 - Healthy Term Infants Fed Milk-Based Infant Formula N/A
Not yet recruiting NCT05428748 - Clinical Trial to Evaluate Safety and Tolerability of a Novel Hydration Drink in Healthy Volunteers N/A
Completed NCT04499482 - Safety and Tolerability of Soy Fiber N/A
Recruiting NCT01207206 - Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients N/A
Completed NCT01038882 - Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy N/A
Completed NCT05794100 - Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance N/A
Completed NCT06187233 - The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation N/A
Completed NCT04055363 - Human Milk Oligosaccharides (HMOs) Post-market Study on Infants N/A
Recruiting NCT03707262 - Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor Phase 1/Phase 2
Completed NCT05585762 - Buck Institute Ketone Ester RCT N/A
Completed NCT02307773 - Lidocaine Spray on an Endoscope to Improve Tolerance to Endoscopy N/A
Completed NCT04188782 - Tolerance to Sevoflurane in Children Undergoing Repeated Drug Exposure
Recruiting NCT05527652 - Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia N/A
Recruiting NCT05088694 - The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain. N/A
Completed NCT06034951 - Acceptability and Tolerance Study of a High Energy Tube Feed With Food Derived Ingredients N/A