Status:
COMPLETED
Safety and Tolerance Study of IBI355 in Health Volunteers
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confir...
Eligibility Criteria
Inclusion
- Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail;
- Healthy male and female aged 18 years or above ;
- Subject with a Body Mass Index (BMI)\* between 18.5 and 28.0 kg/㎡;
- subjects with a normal laboratory examination，ECG， X-ray.
Exclusion
- Subjects with a history of allergy；
- Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
- Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
- HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
- 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;
- Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
- Subject with a hcg positive;
- Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06110338
Start Date
October 30 2023
End Date
September 23 2024
Last Update
October 21 2024
Active Locations (1)
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1
Aerospace Center Hospital
Beijing, Beijing Municipality, China, 100049