Chronic Spontaneous Urticaria
Conditions
Interventions
Experimental group:Cohort1: 50 mg of EVO756 given as one 50 mg tablet, orally. study drug will be administered once on Day 1 and once daily on Days 3 through 9.
Cohort2: 50 mg of EVO756 given as one
Control group:Cohort1: Placebo given as one tablet, orally. and will be administered once on Day 1 and once daily on Days 3 through 9.
Cohort2: Placebo given as one tablet, orally. and will be admi
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: The Chinese healthy participants participating in this study must meet all the following inclusion criteria: 1. Age >= 18 years and = 19.0 and = 50.0 kg, female weight >= 45.0 kg. 3. The researchers consider that the participant's overall health condition is good, and the participant has not suffered from clinically significant diseases or undergone surgery within 4 weeks before the first day of the study. 4. For WOCBP (women of reproductive potential) who have an active sexual life with an unsterilized male partner (an unsterilized male partner is defined as a male who has undergone vasectomy at least 6 months before the screening), they must agree to use an effective contraceptive method for at least 28 days before the first day of the study, throughout the entire study period, and for 90 days after the last administration of the study drug. Effective contraceptive methods are as follows: combined hormonal contraception (including estrogen and progesterone) related to inhibition of ovulation (oral, vaginal, transdermal, injection, implant), pure progesterone contraception related to inhibition of ovulation (oral, injection, implant), intrauterine device (IUD), intrauterine hormone release system (IUS), bilateral tubal occlusion, partner undergoing vasectomy or maintaining abstinence. The reliability of abstinence-based contraceptive methods (such as calendar method, ovulation period method, symptom-based temperature method, or post-ovulation method) should be evaluated based on the duration of the clinical trial, the preferences of the participants, and their daily lifestyles. Periodic abstinence (such as calendar method, ovulation period method, symptom-based temperature method, or post-ovulation method) and external ejaculation method are not considered acceptable contraceptive methods. Non-WOCBP female participants must be in menopause (having no other biological reasons for amenorrhea for at least 12 months, and confirmed without reproductive potential based on the laboratory range at the time of screening, as evidenced by serum FSH) or have undergone surgical sterilization (uterine resection, bilateral ovarian resection, and/or bilateral tubal resection). 5. Male participants who have not undergone vasectomy for at least 6 months before the screening and have an active sexual life with a WOCBP must agree to use an effective barrier contraceptive method from the first administration of the study drug until the last administration and for at least 90 days after the last administration of the study drug. The female partner of the male participant who is a WOCBP and is also a WOCBP should use an acceptable contraceptive method at least 28 days before the first day of the study, throughout the entire study period, and for 90 days after the last administration of the study drug. 6. Male participants must not donate sperm from the first administration of the study drug until 90 days after the last administration. 7. Female participants must not donate oocytes or undergo in vitro fertilization from the first administration of the study drug until 90 days after the last administration. 8. They must be able to provide informed consent, be willing and able to comply with the requirements of the study and the research center.
Exclusion criteria
Exclusion criteria: The Chinese healthy participants participating in this study must not meet any of the following exclusion criteria: 1. During the screening or on the first day, any clinically significant abnormalities were detected in laboratory tests, physical examinations, vital signs, or ECG, and the investigator considered that the participant should be excluded. 2. During the screening, HIV (HIV antibody), hepatitis B* (HBsAg, HBeAg, HBeAb, HBcAb), or hepatitis C (HCV antibody) tests were positive. * If only HBsAb was positive, the participant could be enrolled. If any one of HBsAg, HBeAg, HBeAb, or HBcAb was positive, a HBV-DNA test could be conducted; if the HBV-DNA test result was negative, the participant could be enrolled after the investigator's judgment. 3. During the screening or on the first day, AST or ALT was higher than the upper limit of normal (ULN), or >1.2 times ULN. 4. During the screening or on the first day, there was a history of kidney disease or the creatinine clearance rate was = 220 ms, QRS duration >= 120 ms, or male participants QTcF >= 450 ms, female participants QTcF >= 470 ms). 14. During the screening, there were abnormal vital signs (including systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg or HR 100 bpm). 15. Within 120 days before the first day participated in clinical studies involving investigational or marketed drugs or devices, or simultaneously participated in non-drug or device experimental studies. It is allowed to participate in non-interventional registration studies or epidemiological studies. 16. Within the previous 30 days before the first day, received any vaccine. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Safety ;Tolerance; | — |
Countries
China
Contacts
Public ContactCui Yimin;Zhao Xia
Peking University First Hospital
Outcome results
None listed