Moderate-to-severe atopic dermatitis
Conditions
Interventions
300 mg group:8 cases received the trial drug, 2 cases received placebo
450 mg group:8 cases received the trial drug, 2 cases received placebo
600mg group:8 cases received the trial drug, 2 cases received placebo
75mg group:Receiving trial drugs
150 mg group:8 cases received the trial drug, 2 cases received placebo
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects were enrolled in this study if they met all of the following criteria. 1. Voluntary written informed consent signed by the subject. 2. Healthy males or females, aged 18 to 45 years (including borderline values). 3. Males weighing >= 50 kg and females weighing >= 45 kg with a body mass index (BMI) of 19.0 kg/m^2 <=BMI<=26.0 kg/m^2. 4. No abnormalities in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, frontal and lateral chest No abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, or orthopantomogram, or those whose abnormalities were not considered clinically significant by the investigator 5. Women of childbearing age who have not undergone surgical sterilization or who are less than 1 year post-menopausal at the time of screening Women with negative blood pregnancy test results. Male and female subjects of childbearing potential agree to a minimum of Use effective contraception from 2 weeks prior to screening to 6 months after trial dosing (contraceptive use is prohibited). The use of contraceptive pills is prohibited).
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are not eligible for enrollment in this study. 1. Previous or current circulatory, endocrine, neurological, gastrointestinal system, respiratory system, genitourinary system, hematology, immunology, psychiatry dermatology, ophthalmology, and metabolic abnormalities or any other disease that could interfere with the test results. Any other disease that can interfere with the test results. 2. Persons currently suffering from oral herpes 3. A history of novel coronavirus infection 4. A history of parasitic infestation or recent travel (within 6 months) to a parasitic endemic area. 5. A known history of allergy to any component of the test drug or similar drug, or an allergic person (previous allergic reaction). Allergy (previous allergy to two or more foods or medications or other items). (previous allergy to two or more foods or drugs or other items); a past history of asthma. 6. those who, upon inquiry, have a history of blood or needle sickness and cannot tolerate venipuncture. 7. hepatitis B surface antigen (HBsAg), hepatitis C antibody assay (HCV-AB), human Immunodeficiency virus antigen antibody primary screening (HIVAg/Ab), syphilis spirochete specific antibody (TP) (TP) with positive results for any of these tests. 8. have undergone major surgical procedures within 4 weeks prior to signing informed consent, or are scheduled to undergo surgical procedures during the study period 9. have undergone major surgical procedures within 4 weeks prior to signing informed consent, or are planning to undergo surgical procedures during the study period 10. have taken any medications or supplements (including Chinese herbs) within 14 days prior to signing informed consent medicine) within 14 days prior to signing informed consent. 11. have received a live or live attenuated vaccine within 3 months prior to signing informed consent, or have received a live or live attenuated vaccine within 3 months of signing informed consent, or have received a live vaccine within 3 months of signing informed consent. 12. have received a live or live attenuated vaccine within 3 months prior to signing informed consent, or are scheduled to receive a live or live attenuated vaccine during and within 3 months after the study; and systemic immunosuppression within 3 months prior to signing informed consent; received a biologic agent (antibody or its derivative) prior to signing informed consent received a biologic agent (antibody or its derivative) prior to signing the informed consent and had not completed 5 half-lives. 13. participated in any clinical trial and used any clinical trial drug within 3 months prior to signing informed consent 14. those who participated in any clinical trial and used any clinical trial drug within 3 months prior to signing informed consent 15. donated blood or lost a significant amount of blood (=200 mL, excluding female blood loss during menstruation) within 3 months prior to signing informed consent 16. donated blood or lost a significant amount of blood (=200 mL, excluding menstrual blood loss in women), received a blood transfusion or used blood products within 3 months prior to signing informed consent 17. women who are pregnant or breastfeeding, and who are unable to use one or more non-pharmaceutical contraceptive measures during the trial non-pharmaceutical contraceptive measures during the trial. 18. persons with special dietary requirements who are unable to comply with a unifor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Physical Examination;Laboratory tests;12-lead electrocardiogram;Adverse Events;ADA;Nab;Blood concentration; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital, Central South University
Outcome results
None listed