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The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004.
Up to approximately 40 healthy volunteers across 5 cohorts randomized to receive ZB004 or placebo as single doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZB004 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZB004 | Drug | ZB004 single doses administered subcutaneously as solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004 | Day 1 through Day 99 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent serious adverse events (SAEs) | Day 1 through Day 99 | |
| Number of participants with laboratory abnormalities | Day 1 through Day 99 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NZCR New Zealand Clinical Research | Christchurch | New Zealand |
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| Placebo |
| Drug |
Placebo single doses administered subcutaneously as solution |
|
| Number of participants with Electrocardiogram (ECG) abnormalities |
| Day 1 through Day 99 |
| Maximum observed serum concentration (Cmax) | Day 1 through Day 99 |
| Time for Cmax (Tmax) | Day 1 through Day 99 |
| Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) | Day 1 through Day 99 |
| AUC from time 0 to the last quantifiable concentration (AUClast) | Day 1 through Day 99 |
| Terminal half-life (t½) | Day 1 through Day 99 |
| Apparent clearance following extravascular dosing (CL/F) | Day 1 through Day 99 |
| Apparent volume of distribution following extravascular administration (Vz/F) | Day 1 through Day 99 |