Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College
Chengdu, Sichuan, China
NCT Number: NCT05894148
To evaluate the safety and tolerability of multiple-dose subcutaneous injections of Genakumab for Injection in Chinese healthy adult volunteers.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Chengdu, Sichuan, China
There are 2 dose groups with 12 participants in each group, including 10 participants in the experimental group and 2 participants in the placebo control group. Each subject receives Genakumab or placebo once every four weeks for three times.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group 1: 120mg Q4W,group 2: 200mg Q4W
The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection.
Time frame: Up to 20 weeks
adverse events during the study are to assess the safety of Genakumab.
Time frame: up to 20 weeks
This is to assess pharma co kinetics of Genakumab.
Time frame: up to 20 weeks
This is to assess pharma co kinetics of Genakumab.
Changchun GeneScience Pharmaceutical Co., Ltd.
Industry
A Randomized, Double-Blind, Placebo-Controlled, Multiple-dose Escalation Phase I Study of Genakumab for Injection in Chinese Healthy Adults
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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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