Chronic Spontaneous Urticaria
Conditions
Interventions
Group 1:HY-078020 (dosage 1)
Group 2:HY-078020 (dose 2)/placebo/positive drug
Group 3:HY-078020 (dose 3)/placebo/positive drug
Group 4:HY-078020 (dose 4)/placebo/positive drug
Group 5:HY-078020 (dose 5)/placebo/positive drug
Group 6:HY-078020 (dose 6)/placebo
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Adult male or female subjects aged 18-45 years old (including borderline values); 2. Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg, with a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (including the borderline value), and body mass index (BMI) = body weight (kg)/height2 (m2); 3. Vital signs, physical examination, laboratory tests, electrocardiograms, and other test results of subjects at screening period are normal or abnormal without clinical significance as determined by the investigator; 4. Subjects who promise to have no birth plan or sperm donation plan and voluntarily take effective contraceptive measures from 14 days before screening to 3 months after the last dose (see Appendix 1); 5. Those who fully understand the content, process and possible adverse reactions of the test, and voluntarily participate in the test and sign the informed consent form. Those who do not meet one of the above conditions shall not be enrolled as subjects.
Exclusion criteria
Exclusion criteria: Anyone with one of the following conditions shall be excluded: 1.A history of cardiac, hepatic, neurological, respiratory, haematological, digestive, immunological, renal or psychiatric disease which, in the opinion of the investigator, may confound the results of the study or affect the absorption, distribution, metabolism and excretion of the drug or which, in the judgement of the investigator, is of clinical significance; 2.Suspected hypersensitivity to the study drug or any component of the study drug, or an allergic individual; 3.Those who have undergone surgical procedures within 3 months prior to screening or who plan to undergo surgical procedures during the study; 4.Those who have taken any medication or health product (including herbal medicine) within 14 days prior to screening; 5.Those who have received any vaccine within 1 month prior to screening or who require vaccination during the study (including within 30 days of the last dose of study drug); 6.Those who have used any drug that inhibits or induces hepatic metabolism of a drug within 30 days prior to screening (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticosteroids, omeprazole; depressants-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, vera Pamil, fluoroquinolones, antihistamines); 7. Participating in any clinical trial within 3 months prior to screening and taking clinical trial drugs or using clinical trial equipment; 8.Those who have donated blood or lost a large amount of blood (=400ml), received a blood transfusion or used blood products within 3 months prior to screening; 9.Those with skin scratch disease, or those with broken, red, swollen, hard nodules or scars on the skin of both arms, which, in the opinion of the investigator, affect the results of the histamine prick test adjudicator; 10.A positive pregnancy test or or lactating women; 11.Those who have difficulty in taking blood from veins or those who suffer from needle and bloodsickness; 12.Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250ml) per day; 13.smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to screening or those who were unable to stop using any tobacco-based products during the trial; 14.Alcoholics or regular drinkers in the 6 months prior to screening, i.e. more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of spirits of 40% alcohol by volume or 150ml of wine) or those who are unable to stop the use of any alcohol-containing products during the trial; 15.Those with a history of drug use or a positive screen for substance abuse; 16. Persons with special dietary requirements who are unable to comply with the diet provided and the corresponding regulations, who are unable to avoid xanthine/caffeine-containing beverages (coffee, tea, cola, etc.) or foods (animal liver, chocolate, etc.) 48 hours prior to dosing until the end of the study, or who consume fruits or juices that may interfere with metabolism (grapefruit, pomelo, mango, etc.); 17. Subjects who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerance Outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic outcome;Pharmacodynamic outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed