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This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.
This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KJ103 dose group 1 | Active Comparator | KJ103 single dose |
|
| KJ103 dose group 2 | Active Comparator | KJ103 single dose |
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| KJ103 dose group 3 | Active Comparator | KJ103 single dose |
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| KJ103 dose group 4 | Active Comparator | KJ103 single dose |
|
| KJ103 dose group 5 | Active Comparator | KJ103 single dose |
|
| Matching placebo for each dose group | Placebo Comparator | placebo, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KJ103 | Drug | Recombinant Immunoglobulin G Cleaving Enzyme |
|
| Measure | Description | Time Frame |
|---|---|---|
| AE | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug | Day 1 through Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | The maximum measured concentration of the analysis in serum | Up to 144 hours postdose |
| Tmax | Time To Reach The Maximal serum Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Hamilton | New Zealand Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Auckland | 1010 | New Zealand |
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| Placebo | Drug | Placebo |
|
|
| Up to 144 hours postdose |
| t½ | Terminal Elimination Half-Life | Up to 144 hours postdose |
| AUC0-inf | Area Under the Serum Concentration Versus Time Curve From Zero to Infinity | Up to 144 hours postdose |
| IgG level | Concentration of Immunoglobulin G in serum | Day 1 through Day 63 |