A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose

Korábbi kezelés

• Hypersensitivity to any component of the investigational drug (including excipients), or a history of severe allergic reaction to biologics, or at risk of allergic reactions upon study entry as judged by the investigator;
• Prior expose to anti-IL-17 or anti-IL-17 receptor antibody.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 2 weeks or 5 half lives (whichever is longer) prior to study intervention.
• Vaccination with a live attenuated vaccine within 8 weeks before randomization, or planned vaccination with a live attenuated vaccine during the study;

Más betegség

• History of psychiatric disorders.
• At screening, positive for any of the following in virological testing: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis test.
• At screening, positive or equivocal interferon-gamma release assay (IGRA); or history of tuberculosis.

Egyéb

• Subjects deemed unsuitable for participation in this clinical trial by the investigator.

• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• PART1：bodyweight≤50 kg，at Screening；PART2：bodyweight at screening， female≥45 kg or male≥50 kg and BMI within 18~30（kg/m2）(including margin).
• Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
• Subjects (including male subjects) have no pregnancy plans during the screening period and within 6 months after dosing, voluntarily use effective contraceptive measures, and have no plans to donate sperm or eggs.