Huashan Hospital Affiliated to Fudan University
Shanghai, China
NCT Number: NCT04511624
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
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: IBI112 SC dose1 Drug:placebo
Drug: IBI112 SC dose2 Drug:placebo
Drug: IBI112 SC dose3 Drug:placebo
Drug: IBI112 SC dose4 Drug:placebo
Drug: IBI112 IV dose5 Drug:placebo
Drug: IBI112 SC dose6 Drug:placebo
Drug: IBI112 IV dose7 Drug:placebo
Time frame: Day1 to Day 113 post dose
Time frame: Day 113
IV dose & SC dose
Time frame: Day 113
SC dose
Time frame: Day 113
IV dose & SC dose
Time frame: Day 113
IV dose & SC dose
Time frame: Day 113
IV dose & SC dose
Innovent Biologics (Suzhou) Co. Ltd.
Industry
A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in 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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