A Study of Two Different Formulations of 611 in Healthy Adult Subjects in China

Korábbi kezelés

• Previous or current disease that may affect the safety of the subject's participation in the trial or the in vivo process of the trial drug;
• History of drug abuse within 2 years prior to screening;
• Alcoholism within 3 months prior to screening;
• Those who smoke more than 5 cigarettes per day within 3 months before screening or cannot give up smoking during the period from signing the informed consent of the subject to leaving the group;
• Those who have consumed more than 1L of strong tea, coffee and/or caffeinated beverages per day within 3 months before screening, and who have ingested chocolate or any food or drink containing caffeine, theophylline, theobromine or alcohol within 48 hours before the study administration;
• Presence of active infection requiring systemic treatment prior to screening or dosing;
• Those who have used any prescription drugs, over-the-counter drugs, vitamin products or Chinese herbal medicines within 4 weeks or 5 half lives (whichever is longer) before dosing, or those who may need to receive other drugs during the trial;
• Participated in the clinical trial of any drug or device within 3 months or 5 half-lives before dosing;
• Receipt of any marketed or investigational biologic within 3 months or 5 half lives prior to dosing;
• Live vaccine or live attenuated vaccine within 2 months prior to dosing or planned administration during the study;
• Previous use of any IL-4Rα target drugs;

Más betegség

• History of severe allergies or allergies to 611 and any of its components;
• Any history of VKC and AKC;
• Have active tuberculosis;

Egyéb

• Pregnant or lactating females;

• Willingness to provide written informed consent for the study.
• Male or female subjects, age 18-45 years older.
• Within body mass index (BMI) range 19.0 to 26.0 kilograms per square meter (kg/m²).
• The results of vital signs, physical examination, laboratory tests, electrocardiogram, chest X-ray and other examinations during the screening period are normal or judged to be abnormal by the investigator and have no clinical significance.
• Males and females of non-childbearing potential.