Rheumatoid Arthritis
Conditions
Interventions
Fasted Group:EVT 401 Tablets (Fed)
Fasted Group:EVT 401 Tablets (Fasted)
Sponsors
The Fifth Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Study participants must meet all of the following criteria to be enrolled in the trial: 1.Be capable of understanding the procedures and methods of this study: 1. Ability to understand the procedures and methods of this study, maintain good communication with the investigator, willingness to strictly comply with the requirements of the clinical trial protocol and scheduled follow-ups, and voluntary participation in this study with written informed consent signed; 2. Chinese healthy adult participants, both male and female, aged >=18 and =50.0 kg, female participants with body weight >=45.0 kg; Body Mass Index (BMI) within the range of 19.0–26.0 kg/m^2 (including boundary values; BMI = body weight (kg) / height (m^2)); 4. From the signing of the informed consent form until 6 months after the end of the trial, participants must ensure no plans for procreation. Female participants must have no egg donation plan and agree to take reliable measures to avoid pregnancy; male participants must have no sperm donation plan and agree to take reliable measures to avoid pregnancy in their partners.
Exclusion criteria
Exclusion criteria: Study participants who meet any of the following criteria will be excluded from the trial : 1. Have a history of any clinically significant disease or are currently suffering from related diseases: (1) Including but not limited to diseases of the respiratory system (e.g., history of tuberculosis or active pulmonary tuberculosis), cardiovascular system, digestive system, urinary system, musculoskeletal system, endocrine system (e.g., history of adrenocortical insufficiency), neurological and psychiatric system (e.g., epilepsy), hematological system, immune system, etc.; (2) History of clinically significant anesthesia accidents; (3) Known severe bleeding tendency; (4) History of genetic diseases such as malignant hyperthermia; (5) Severe infection, trauma, or surgery within 12 weeks prior to screening that, in the investigator's judgment, makes the participant unsuitable for the trial; (6) Occurrence of clinically significant acute diseases, such as gastrointestinal diseases or infections, within 4 weeks prior to screening; (7) History of gastroesophageal reflux disease for more than two weeks within 3 months prior to screening; (8) Study participants with chronic pain or experiencing acute pain (referring to pain lasting less than 3 months) upon inquiry; 2. Have a history of significant allergies, including known allergies to any drug or any component of the investigational drug, history of food allergies, pollen allergies, or other allergies; 3. Upon inquiry, have smoked more than 5 cigarettes per day or an equivalent amount of tobacco within 3 months prior to the screening period, or are unable to refrain from using any tobacco products during the trial period; 4. Upon inquiry, have a history of alcohol abuse, or have an average weekly alcohol consumption of >=14 units within 3 months prior to the screening period (1 unit = 45 mL of high-proof liquor / 150 mL of wine / 350 mL of beer), or are unable to abstain from alcohol during the trial period; 5. Have used drugs known to cause damage to major organs within 3 months prior to the trial; have used hepatic enzyme inducers (including phenobarbital, phenytoin sodium, rifampicin, glutethimide, griseofulvin, etc.) or hepatic enzyme inhibitors (including macrolide antibiotics, azole antifungals, calcium channel blockers, etc.) within 1 month prior to screening; have used any medication (including any prescription drugs, over-the-counter drugs, herbal medicines) or health supplements within 2 weeks prior to enrollment, and the time is less than 5 half-lives of the drug or less than 4 weeks (whichever is longer); unless both the principal investigator and the sponsor agree that the medication used has no impact on the safety and PK/PD results of this trial, enrollment may be permitted; 6. Have consumed, within 72 hours prior to screening, or are unable to refrain from consuming during the study, foods or beverages containing caffeine (such as coffee, strong tea, cola, chocolate, etc.), or other foods that affect drug absorption, distribution, metabolism, or excretion (such as dragon fruit, mango, grapefruit, pomelo, orange, star fruit, guava, etc.); 7. Have participated in any drug clinical trial within 3 months prior to screening, or plan to participate in other clinical trials during the study period; 8. Have received vaccination (including but not limited to COVID-19, tetanus, rabies, HPV vaccines, etc.) within 2 months prior to screen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events,Adverse Reactions,Serious Adverse Events;Pharmacokinetic (PK) Parameters;Pharmacodynamic (PD) Exploratory Parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| PD parameters of EVT401;PK parameters of EVT401; | — |
Countries
China
Contacts
Public ContactTenghua Wang
The Fifth Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed