Status:
COMPLETED
Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects
Detailed Description
In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.
Eligibility Criteria
Inclusion
- Healthy male or female 18 to 45 years of age at the time of consent
- BMI of 19-26Kg/m2 and weight of 50-100kg
- Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements
Exclusion
- Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine
- Subjects who have a history of relapse or chronic infection, or a history of acute infection within 2 weeks;
- Subjects who have previously used anti-IL-12 / 23 or anti-il-23 drugs;
- Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
- Subjects who are not suitable for this trial due to other reasons In the investigator' opinion
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04511624
Start Date
August 27 2020
End Date
July 22 2022
Last Update
September 19 2022
Active Locations (1)
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1
Huashan Hospital Affiliated to Fudan University
Shanghai, China