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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001128-36 | EudraCT Number |
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This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort.
Sixty-four subjects are planned to be studied in eight cohorts in this first-in human trial. Eight subjects will be allocated to the to eight dose levels. The entire observation period comprise 28 days starting with a 96 hours in-house stay, where discharge is planned for Day 5, followed by five outpatient visits and an End of Trial Visit at Day 28. A blinded evaluation of each cohort will be performed by a Trial Safety Group to determine whether the trial will progress to the next dose level based on the stopping rules specified in protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP7570 | Active Comparator | Single subcutaneous injection |
|
| Placebo | Placebo Comparator | Single subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual GLP-1/GLP-2 Receptor agonists | Drug | Eight ascending doses of ZP7570 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Incidence of adverse events (AEs) | The incidence, type and severity of adverse events (AEs) | From time zero to 28 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Area under the plasma concentration-time curve trough | AUCτ, Area under the plasma concentration-time curve (AUC) from zero up to trough concentration. | From time zero up to day 28 |
| Pharmacokinetics - Area under the plasma concentration-time curve infinity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hövelmann, MD | Profil Neuss, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung GmbH | Neuss | North Rhine-Westphalia | 41460 | Germany |
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A randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo
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AUCinf, Area under the plasma concentration-time curve (AUC) from zero up to last concentration. |
| From time zero up to day 28 |
| Pharmacokinetics - Area under the plasma concentration-time curve last | AUClast, Area under the plasma concentration-time curve (AUC) from zero up to last concentration | From time zero up to day 28 |
| Pharmacokinetics - Maximum plasma concentration | Measured maximum plasma drug concentration after dosing, Cmax | From time zero to 28 days after dosing |
| Pharmacokinetics - Time to maximum plasma concentration (Tmax) | Sampling time until reaching Cmax, Tmax | From time zero to 28 days after dosing |
| Pharmacokinetics - Half-life , t½ | Half-life of ZP7570, t½ | From time zero to 28 days after dosing |
| Pharmacokinetics - Volume of distribution | Apparent volume of distribution of ZP7570, Vz/f | From time zero to 28 days after dosing |
| Pharmacokinetics - Mean residence time | Mean residence time, MRT | From time zero to 28 days after dosing |
| Pharmacokinetics - Body clearance | Total body clearance, CL/f | From time zero to 28 days after dosing |
| Pharmacokinetics - Elimination rate constant | Elimination rate constant, λz | From time zero to 28 days after dosing |
| Pharmacodynamics - Plasma glucose levels | Plasma glucose levels included with the acetaminophen at specific timepoints relative to a Mixed Test Meal | Time Frame: 0-240 minutes |
| Pharmacodynamics - Insulin concentrations | Insulin concentrations included with the acetaminophen at specific timepoints relative to a Mixed Test Meal | Time Frame: 0-240 minutes |
| Pharmacodynamics - Plasma acetaminophen concentration-time curves | Plasma acetaminophen concentration-time curves following ingestion of acetaminophen | Time Frame: 0-240 minutes |
| Pharmacodynamics - Maximum acetaminophen concentration | Change from baseline acetaminophen to maximum acetaminophen | Time Frame: 0-240 minutes |
| Pharmacodynamics - Time maximum acetaminophen concentration | Time to maximum change in acetaminophen measure from baseline, Tmax | Time Frame: 0-240 minutes |
| Safety - Safety lab, haematology | Changes in haematology parameters: Haematocrit, Haemoglobin, Erythrocytes, MCV, MCH, MCHC, platelets, Leucocytes, Neutrophile granulocytes (total count and relative), Lymphocytes (total count and relative), Monocytes (total count and relative), Eosinophile granulocytes (total count and relative), Basophile granulocytes (total count and relative) | From time zero to 28 days after dosing |
| Safety - Safety lab, clinical chemistry | Changes in clinical chemistry parameters: Sodium, Potassium, Calcium, Creatinine, Urea, AST, ALT, gamma-GT, Uric acid, Total protein, Albumin, Total bilirubin, Creatine kinase, Alkaline phosphatase, LDH, Total cholesterol, LDL, HDL, Amylase, Triglycerides, Lipase | From time zero to 28 days after dosing |
| Safety - Safety lab, urinalysis | Changes in urinalysis: Protein, Glucose Erythrocytes, Leucocytes, pH, ketones | From time zero to 28 days after dosing |
| Safety - Vital signs, blood pressure | Changes in vital signs, blood pressure (in mmHG) | From time zero to 28 days after dosing |
| Safety - Vital signs, pulse | Changes in pulse (beats per minute) | From time zero to 28 days after dosing |
| Safety - Physical examination | Changes in physical examination of body sections (head, chest and heart, abdomen, skin and mucosae, musculoskeletal system, nervous system, lymph node) | From time zero to 28 days after dosing |
| Safety - ECG | Occurrence of ECG findings, Changes in ECG parameters (in ms). ECG components: Heart rate, PR, QRS, QT and QTcF. | From time zero to 28 days after dosing |
| Safety - Occurrence of Injection site reactions | Occurrence of injection site reactions | From time zero to 28 days after dosing |
| Safety - Immunogenicity: Occurrence of anti-drug antibodies | Occurrence of anti-drug antibodies | From time zero to 28 days after dosing |