Safety and Tolerability of IBI355 in Healthy Volunteers

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

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called IBI355 to see how safe it is and how well it is tolerated by healthy volunteers. The researchers want to understand how the drug behaves in the body and whether it triggers any immune responses after receiving multiple doses. The study is currently active, but they are not looking for new participants at this time.

To be eligible for this trial, participants must be at least 18 years old, have a body mass index (BMI) between 18 and 28, and be in good health with no significant medical history. This means they should not have any allergies, infections, or serious health issues that could affect their safety during the study. Those who join the trial will receive the medication in increasing amounts to see how their bodies react, and they will be closely monitored throughout the process. This trial is an important step in testing IBI355, which could lead to more effective treatments in the future.

Gender

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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