Rheumatoid Arthritis
Conditions
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: The research participants must meet the following criteria to be included in the trial: 1. They must be able to understand the procedures and methods of this study, maintain good communication with the researchers, strictly abide by the requirements of the trial protocol and follow up on schedule, voluntarily participate in this study and sign a written informed consent form; 2. When signing the informed consent form, the Chinese healthy adult research participants should be aged between 18 and 50 years old (inclusive), both male and female are acceptable; 3. During the screening period, male research participants should have a weight of >= 50.0 kg, and female participants should have a weight of >= 45.0 kg; their body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m^2 (including the boundary values: BMI = weight (kg) / height (m^2)); 4. From the date of signing the informed consent form until the end of the trial, the research participants must ensure that they have no fertility plans, female participants have no egg donation plans and agree to take reliable measures to avoid pregnancy, and male participants have no sperm donation plans and agree to take reliable measures to prevent their partners from getting pregnant.
Exclusion criteria
Exclusion criteria: Any of the following items would be considered as exclusion criteria for this trial: 1. Individuals with any history of severe clinical diseases or those currently suffering from related diseases: (1) Including but not limited to respiratory system (such as those with a history of tuberculosis or active pulmonary tuberculosis), cardiovascular system, digestive system, urinary system, musculoskeletal system, endocrine system (such as adrenal cortical insufficiency history), nervous and mental system (such as epilepsy), blood system, immune system, etc. diseases with clinically significant anesthesia accidents history, known severe bleeding tendency conditions; (2) Genetic diseases such as malignant hyperthermia; (3) Those who had severe infections, injuries or surgeries within 12 weeks before screening and the investigator judged as not suitable for the trial; (4) Those who had acute diseases with clinically significant significance within 4 weeks before screening, such as gastrointestinal diseases, infections; (5) Those who had a history of gastroesophageal reflux for more than two weeks before screening; (6) Those who were asked to have chronic pain or were experiencing acute pain; 2. Those with a significant history of allergies, including those allergic to known drugs or any component of the trial drugs or having a history of food allergies or pollen allergies or other allergies; 3. Those who smoked more than 5 cigarettes per day or an equivalent amount of tobacco within 3 months before screening, or those who could not stop using any tobacco products during the trial; 4. Those who had a history of heavy drinking, or within 3 months before screening, had an average weekly alcohol consumption of >= 14 units (1 unit = 45 mL of strong liquor / 150 mL of wine / 350 mL of beer), or those who could not stop drinking during the trial; 5. Those who had used known drugs that cause damage to major organs within 3 months before the trial; those who used liver enzyme inducers (including phenobarbital, phenytoin sodium, rifampicin, grumet, griseofulvin, etc.) or liver enzyme inhibitors (including macrolide antibiotics, azole antifungal drugs, calcium channel antagonists, etc.) within 1 month before the trial; those who used any drugs (including any prescription drugs, over-the-counter drugs, Chinese herbal medicines) and health supplements within 2 weeks before enrollment, and the duration was shorter than 5 half-lives of the drug or less than 4 weeks (whichever is longer); unless the principal investigator and the sponsor jointly consider that the used drugs have no impact on the safety and PK/PD results of this trial, then they can be enrolled; 6. Those who could not stop consuming foods or beverages containing caffeine (such as coffee, strong tea, cola, chocolate, etc.) or other foods that affect drug absorption, distribution, metabolism, and excretion (such as dragon fruit, mango, grapefruit (citrus), tangerine, orange, rambutan, guava, etc.) within 72 hours before screening or during the study; 7. Those who participated in any drug clinical trials within 3 months before screening or planned to participate in other clinical trials during the study; 8. Those who received vaccinations (including but not limited to COVID-19, tetanus, rabies, HPV, etc.) within 2 months before screening; 9. Those who donated blood or had a large amount of blood loss (>= 400 mL) or received blood transfusion or used blood products within 30 days before screening; t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events,Adverse Reactions,Serious Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of EVT401;PD parameters of EVT401; | — |
Countries
China
Contacts
Public ContactWang Tenghua
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed