Safety and Tolerability of IBI355 in Healthy Volunteers

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · May 15, 2024

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Understanding and Signing a written informed consent prior to selection;
• • 2. Aged above 18 years old, male or female;
• • 3. Body mass index (BMI) between 18-28kg/m2;
• • 4. Normal label test;
• • 5. No parenting plan for at least 6 months
• Exclusion Criteria:
• • 1. Subjects with a history of allergy；
• • 2. Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
• • 3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
• • 4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
• • 5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
• • 6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
• • 7. Subject with a hcg positive;
• • 8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial