- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02390141
Multiple Ascending Doses of ZP4207 Administered to HV to Evaluate the Safety, Tolerability, PKs and PDs of ZP4207
November 10, 2015 updated by: Zealand Pharma
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Neuss, Germany, 41460
- Profil GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ulrike Hövelmann, MD, Profil GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
February 28, 2015
First Submitted That Met QC Criteria
March 10, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Estimate)
November 11, 2015
Last Update Submitted That Met QC Criteria
November 10, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
-
University of UlmRecruitingHypoglycemia, ReactiveGermany
-
University of ArizonaNot yet recruiting
-
Milton S. Hershey Medical CenterDexCom, Inc.; Children's Miracle NetworkRecruiting
-
Zealand University HospitalUnknownHypoglycemia, ReactiveDenmark
-
MBX BiosciencesProSciento, Inc.RecruitingPostbariatric HypoglycemiaUnited States
-
University Hospital, Basel, SwitzerlandBoehringer IngelheimRecruitingPostprandial HypoglycemiaSwitzerland
-
University of NebraskaCompletedNeonatal HypoglycemiaUnited States
-
Vogenx, Inc.CompletedPostbariatric HypoglycemiaUnited States
-
Stanford UniversityCompletedNeonatal HypoglycemiaUnited States
-
Diva De LeonLester and Liesel Baker FoundationCompletedPostprandial HypoglycemiaUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States