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The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: HB0034 dose group 1 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Active Comparator: HB0034 dose group 2 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Active Comparator: HB0034 dose group 3 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Active Comparator: HB0034 dose group 4 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Active Comparator: HB0034 dose group 5 | Experimental | 6 subjects receive a single-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Active Comparator: HB0034 dose group 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB0034 | Drug | Recombinant Humanized Anti-IL-36R Monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 the investigational drug | up to 113 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum measured concentration of the analysis in plasma | Up to 113 days |
| AUC0-infinity | The area under the concentration-time curve of the analysis in plasma over the time interval from 0 extrapolated to infinity |
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Inclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Tang | Contact | +86 15821321563 | yuan.tang@huaota.com | |
| Qiaoxia Qian | Contact | +86 18555690860 | qiaoxia.qian@huaota.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | China |
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| Experimental |
8 subjects receive a multi-dose of HB0034, a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Active Comparator: HB0034 dose group 7 | Experimental | 8 subjects receive a multi-dose of HB0034 a recombinant humanized anti-IL-36R IgG1 monoclonal antibody |
|
| Placebo group | Placebo Comparator | 17 subjects receive placebo |
|
| HB0034 matching placebo | Drug | HB0034 matching Palcebo |
|
| up to 113 days |