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The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.
This is a single-dose escalation study of HB0056 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0056.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB0056 dose group 1 | Active Comparator | HB0056 single dose |
|
| HB0056 dose group 2 | Active Comparator | HB0056 single dose |
|
| HB0056 dose group 3 | Active Comparator | HB0056 single dose |
|
| HB0056 dose group 4 | Active Comparator | HB0056 single dose |
|
| HB0056 dose group 5 | Active Comparator | HB0056 single dose |
|
| HB0056 dose group 6 | Active Comparator | HB0056 single dose |
|
| HB0056 dose group 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB0056 | Drug | HB0056 Injection |
|
| 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 investigational drug | Up to 2700 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum measured concentration of the analysis in plasma. | Up to 2700 hours |
| 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jingjing Wang | Contact | 086 15002154126 | jingjing.wang@huaota.com | |
| Xiaoyan Liu | Contact | 086 15002154126 | xiaoyan.liu@huaota.com |
| Name | Affiliation | Role |
|---|---|---|
| Cory Sellwood | New Zealand Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Recruiting | Christchurch | 8011 | New Zealand |
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| Active Comparator |
HB0056 single dose |
|
| Matching placebo for each dose group | Placebo Comparator | placebo, single dose |
|
|
| Placebo | Drug | Placebo |
|
|
| Up to 2700 hours |