The First Affiliated
Zhengzhou, Henan, 450000, China
NCT Number: NCT06277752
A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Zhengzhou, Henan, 450000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IBI128 300mg po. QD(Quaque Die)
IBI128 25mg po. QD(Quaque Die)
IBI128 50mg po. QD(Quaque Die)
IBI128 200mg po. QD(Quaque Die)
IBI128 100mg po. QD(Quaque Die)
Time frame: Up to Day 8
Maximum plasma concentration(Cmax) of IBI128
Time frame: Up to Day 8
Area under the concentration-time curve (AUC)of IBI128
Time frame: Up to Day 8
Time to ahieve Cmax
Time frame: Up to Day 8
The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.
Time frame: Up to Day 8
Number of subjects with Adverse Event
Time frame: Up to Day 8
The Percentage change of serum UA assesed by Area Under Curve 24,Cmean,24,Cmean,24 of IBI128 from baseline.
Time frame: Up to Day 8
Number of subjects with Serious Adverse Event
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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