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The trial is a single-centre, randomized, double-blind, phase 1b trial of multiple ascending doses of ZP4207 administered s.c. to healthy volunteers (HV) to evaluate the safety, tolerability, pharmakocinetic (PK) and pharmacodynamic (PD). Three cohorts of 8 subjects are planned. Within each cohort, the subjects will be randomly assigned to five repeated doses of ZP4207 or placebo in a 3:1 treatment allocation at trial site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP4207 | Experimental | Five multiple doses of ZP4207 in ascending doses |
|
| Placebo | Placebo Comparator | Five multiple doses of corresponding placebo in ascending doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZP4207 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of participants with adverse events | 28 days |
| Number of participants with adverse events | Changes or findings from baseline (normal ranges) in clinical safety laboratory assessments (including haematology, biochemistry, coagulation and urinalysis). | 28 days |
| Number of participants with adverse events | Changes or findings from baseline in physical examination including Head, ears, eyes, nose, throat (HEENT), incl. thyroid gland
| 28 days |
| Number of participants with adverse events | Changes or findings from baseline in vital signs (including systolic and diastolic blood pressure (mmHG) und heart rate (beats per minute), body temperature (°C), respiratory frequency (RF/min)) | 28 days |
| Number of participants with adverse events | Changes or findings from baseline in ECG Parameter (Heart rate, PQ, QRS, QT, QTcB) | 28 days |
| Number of participants with adverse events | Findings in local tolerability by means of the following assessments:
| 28 days |
| Number of participants with adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Areas under the plasma concentration curve compared between first and last dosing | Areas under the plasma concentration curve from 0 until 300min | 5h |
| Areas under the plasma concentration curve compared between first and last dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Hövelmann, MD | Profil GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil GmbH | Neuss | 41460 | Germany |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
Immunogenicity (Anti-ZP4207 Antibodies) |
| 28 days |
Areas under the plasma concentration curve from 0 until infinity
| 5 h |
| Plasma concentration curve compared between first and last dosing | Maximum observed ZP4207 concentration | 5 h |
| Plasma concentration curve compared between first and last dosing | Time to maximum observed ZP4207 concentration | 5 h |
| Plasma concentration curve compared between first and last dosing | Terminal elimination rate constant of ZP4207 | 5 h |
| Plasma concentration curve compared between first and last dosing | Terminal plasma elimination half-life calculated as t½=ln2/λz | 5 h |
| Plasma concentration curve compared between first and last dosing | Apparent volume of distribution of ZP4207 based on plasma concentration values, estimated during the terminal phase | 5 h |
| Pharmacokinetic endpoints compared between first and last dosing | Apparent plasma clearance rate of ZP4207 estimated during the terminal phase | 5 h |
| Pharmacokinetic endpoints compared between first and last dosing | Mean residence time for plasma ZP4207 | 5 h |
| Pharmacodynamic endpoints compared between first and last dosing | Area under the plasma glucose curve from 0 until 300min | 5 h |
| Pharmacodynamic endpoints compared between first and last dosing | Maximum observed plasma glucose concentration | 5 h |
| Pharmacodynamic endpoints compared between first and last dosing | Time to maximum plasma glucose concentration | 5 h |
| Pharmacodynamic endpoints compared between first and last dosing | Delta (time to increase) of glucose of 2 mmol/ | 5 h |