Multiple Ascending Doses of ZP4207 Administered to HV to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207
A Randomized, Placebo-controlled, Double-blind Trial of Multiple Ascending Doses of ZP4207 Administered to Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP4207
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Neuss, Germany, 41460
- Profil GmbH
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedures that would not have been performed during normal management of the subject).
- Caucasian
- Healthy male subject.
- Age between 18 and 50 years, both inclusive.
- Body weight between 70 and 90 kg (both inclusive)
- Fasting plasma glucose concentration <= 100 mg/dL.
- Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator.
Exclusion Criteria:
- Known or suspected hypersensitivity to IMP or related products.
- Previous participation in this trial. Participation is defined as randomized.
- Previous treatment with ZP4207.
- Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
- History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
- Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological, haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness as judged by the Investigator.
- Any serious systemic infectious disease during four weeks prior to first dosing of the study drug, as judged by the Investigator.
- Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator.
- Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 95-140 mmHg blood pressure and for diastolic greater than 90 mmHg or symptoms and a heart rate at rest outside the range of 50-90 beats per minute (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial).
- Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
- Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer, one glass of wine of 120 mL, or 20 mL spirits).
- A positive result in the alcohol and/or urine drug screen at the screening visit.
- Smoker (defined as a subject who is smoking more than 7 cigarettes or the equivalent per week) within the last month prior to screening and who is not able or willing to refrain from smoking and use of nicotine substitute products one day before first dosing and during the treatment period.
- Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
- Any medication (prescription and non-prescription drugs) within 14 days before IMP administration, with the exception of paracetamol or acetylsalicylic acid for occasional use to treat acute pain.
- Blood donation or blood loss of more than 500 mL within the last 3 months.
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation.
- Male who is sexually active and not surgically sterilized who and whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures include surgical sterilisation, hormonal intrauterine devices [coil], oral hormonal contraceptives, each in combination with spermicide-coated condoms), or who is not willing to refrain from sexual intercourse from the first dosing until 1 month after last dosing in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: ZP4207
Five multiple doses of ZP4207 in ascending doses
|
|
|
Placebo Comparator: Placebo
Five multiple doses of corresponding placebo in ascending doses
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with adverse events
Time Frame: 28 days
|
Number of participants with adverse events
|
28 days
|
|
Number of participants with adverse events
Time Frame: 28 days
|
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
Time Frame: 28 days
|
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
Time Frame: 28 days
|
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
Time Frame: 28 days
|
Changes or findings from baseline in ECG Parameter (Heart rate, PQ, QRS, QT, QTcB)
|
28 days
|
|
Number of participants with adverse events
Time Frame: 28 days
|
Findings in local tolerability by means of the following assessments:
|
28 days
|
|
Number of participants with adverse events
Time Frame: 28 days
|
Immunogenicity (Anti-ZP4207 Antibodies)
|
28 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Areas under the plasma concentration curve compared between first and last dosing
Time Frame: 5h
|
Areas under the plasma concentration curve from 0 until 300min
|
5h
|
|
Areas under the plasma concentration curve compared between first and last dosing
Time Frame: 5 h
|
Areas under the plasma concentration curve from 0 until infinity
|
5 h
|
|
Plasma concentration curve compared between first and last dosing
Time Frame: 5 h
|
Maximum observed ZP4207 concentration
|
5 h
|
|
Plasma concentration curve compared between first and last dosing
Time Frame: 5 h
|
Time to maximum observed ZP4207 concentration
|
5 h
|
|
Plasma concentration curve compared between first and last dosing
Time Frame: 5 h
|
Terminal elimination rate constant of ZP4207
|
5 h
|
|
Plasma concentration curve compared between first and last dosing
Time Frame: 5 h
|
Terminal plasma elimination half-life calculated as t½=ln2/λz
|
5 h
|
|
Plasma concentration curve compared between first and last dosing
Time Frame: 5 h
|
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
Time Frame: 5 h
|
Apparent plasma clearance rate of ZP4207 estimated during the terminal phase
|
5 h
|
|
Pharmacokinetic endpoints compared between first and last dosing
Time Frame: 5 h
|
Mean residence time for plasma ZP4207
|
5 h
|
|
Pharmacodynamic endpoints compared between first and last dosing
Time Frame: 5 h
|
Area under the plasma glucose curve from 0 until 300min
|
5 h
|
|
Pharmacodynamic endpoints compared between first and last dosing
Time Frame: 5 h
|
Maximum observed plasma glucose concentration
|
5 h
|
|
Pharmacodynamic endpoints compared between first and last dosing
Time Frame: 5 h
|
Time to maximum plasma glucose concentration
|
5 h
|
|
Pharmacodynamic endpoints compared between first and last dosing
Time Frame: 5 h
|
Delta (time to increase) of glucose of 2 mmol/
|
5 h
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Ulrike Hövelmann, MD, Profil GmbH
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ZP4207-15007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoglycemia
-
NCT07582874AvailablePost-bariatric Hypoglycemia
-
NCT06473480RecruitingHyperglycemia | Diabetes Mellitus | Hypoglycemia (Diabetic) | Hypoglycemia Night
-
NCT07375615CompletedHyperglycemia | Hypoglycemia | Hypoglycemia Neonatal
-
NCT07217483RecruitingNeonatal Hypoglycemia
-
NCT07259629RecruitingAnesthesia | Pediatrics | Hypoglycemia; Iatrogenic
-
NCT04811612Not yet recruitingNeonatal Hypoglycemia
-
NCT06182527Completed
-
NCT03514576UnknownHypoglycemia, Reactive
-
NCT07029412RecruitingPostbariatric Hypoglycemia
Clinical Trials on Placebo
-
NCT03827590UnknownAcute Bronchitis | Acute Upper Respiratory Tract Infection
-
NCT02177513Completed
-
NCT06767540Not yet recruiting
-
NCT02935712CompletedMale Subjects With Type II Diabetes (T2DM)
-
NCT03198624CompletedPharmacokinetics | Safety Issues
-
NCT02982187CompletedPulmonary Disease, Chronic Obstructive
-
NCT04693039Completed
-
NCT01610388Completed
-
NCT01550471CompletedAsthma | Allergic Rhinitis