Central Hospital affiliated to Shandong First Medical University
Jinan, Shandong, China
Location status: Recruiting
NCT Number: NCT06716151
The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Jinan, Shandong, China
Location status: Recruiting
This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
Exclusion criteria
Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)
Recombinant Humanized Anti-IL-36R Monoclonal antibody
HB0034 matching Palcebo
Time frame: up to 113 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational drug
Time frame: Up to 113 days
The maximum measured concentration of the analysis in plasma
Time frame: up to 113 days
The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity
Contact information is provided by the study sponsor or research team.
Qiaoxia Qian
CONTACT
Yuan Tang
CONTACT
Shanghai Huaota Biopharmaceutical Co., Ltd.
Industry
A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult 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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