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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.
This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB0034 dose group 1 | Active Comparator | HB0034 single dose |
|
| HB0034 dose group 2 | Active Comparator | HB0034 single dose |
|
| HB0034 dose group 3 | Active Comparator | HB0034 single dose |
|
| HB0034 dose group 4 | Active Comparator | HB0034 single dose |
|
| HB0034 dose group 5 | Active Comparator | HB0034 single dose |
|
| HB0034 dose group 6 | Active Comparator | HB0034 single dose |
|
| HB0034 dose group 7 |
| 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 investigational drug | up to 2000 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum measured concentration of the analysis in plasma | up to 2000 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Schwabe | NZCR OpCo limited AKL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New zealand Clinical Research | Auckland | New Zealand |
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| Active Comparator |
HB0034 single dose |
|
| Matching placebo for each dose group | Placebo Comparator | placebo, single dose |
|
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| Placebo | Drug | Palcebo |
|
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