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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064345
Other study ID # HB0034-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 3, 2021
Est. completion date September 1, 2022

Study information

Verified date November 2021
Source Shanghai Huaota Biopharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose.


Description:

This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Healthy male or female subjects age = 18 and = 55 years. - Body Mass Index (BMI) = 17.5 and = 32 kg/m². - Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant. - Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation. Exclusion Criteria: - History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease. - Current or history of malignancy. - Family history of premature Coronary Heart Disease (CHD) - History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia). - Pregnant or Breasting feeding subject. Women with a positive pregnancy test (HCG). - Further exclusions criteria apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HB0034
Recombinant Humanized Anti-IL-36R Monoclonal antibody
Placebo
Palcebo

Locations

Country Name City State
New Zealand New zealand Clinical Research Auckland

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Huaota Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Other AUC0-infinity The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity up to 2000 hours
Primary Percentage of subjects with drug related adverse events (AEs) An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug up to 2000 hours
Secondary Cmax The maximum measured concentration of the analysis in plasma up to 2000 hours
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