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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Profil GmbH
Neuss, Germany
Number of participants with adverse events
Number of participants with adverse events
Time frame: 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).
Time frame: 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 * Heart, lung, chest * Abdomen * Skin and mucosae * Musculoskeletal system * Nervous system * Lymph node * Other findings)
Time frame: 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))
Time frame: 28 days
Number of participants with adverse events
Changes or findings from baseline in ECG Parameter (Heart rate, PQ, QRS, QT, QTcB)
Time frame: 28 days
Number of participants with adverse events
Findings in local tolerability by means of the following assessments: * spontaneous pain * pain on palpation * itching * redness * oedema * induration/infiltration * other
Time frame: 28 days
Number of participants with adverse events
Immunogenicity (Anti-ZP4207 Antibodies)
Time frame: 28 days
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Areas under the plasma concentration curve compared between first and last dosing
Areas under the plasma concentration curve from 0 until 300min
Time frame: 5h
Areas under the plasma concentration curve compared between first and last dosing
Areas under the plasma concentration curve from 0 until infinity
Time frame: 5 h
Plasma concentration curve compared between first and last dosing
Maximum observed ZP4207 concentration
Time frame: 5 h
Plasma concentration curve compared between first and last dosing
Time to maximum observed ZP4207 concentration
Time frame: 5 h
Plasma concentration curve compared between first and last dosing
Terminal elimination rate constant of ZP4207
Time frame: 5 h
Plasma concentration curve compared between first and last dosing
Terminal plasma elimination half-life calculated as t½=ln2/λz
Time frame: 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
Time frame: 5 h
Pharmacokinetic endpoints compared between first and last dosing
Apparent plasma clearance rate of ZP4207 estimated during the terminal phase
Time frame: 5 h
Pharmacokinetic endpoints compared between first and last dosing
Mean residence time for plasma ZP4207
Time frame: 5 h
Pharmacodynamic endpoints compared between first and last dosing
Area under the plasma glucose curve from 0 until 300min
Time frame: 5 h
Pharmacodynamic endpoints compared between first and last dosing
Maximum observed plasma glucose concentration
Time frame: 5 h
Pharmacodynamic endpoints compared between first and last dosing
Time to maximum plasma glucose concentration
Time frame: 5 h
Pharmacodynamic endpoints compared between first and last dosing
Delta (time to increase) of glucose of 2 mmol/
Time frame: 5 h