A Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570

December 1, 2020 updated by: Zealand Pharma

A First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of ZP7570 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early 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

  • Germany
    • North Rhine-Westphalia
      • Neuss, North Rhine-Westphalia, Germany, 41460
        • Profil Institut für Stoffwechselforschung 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female subject aged between 18 and 55 years, both inclusive.
  • Body Mass Index (BMI) between 18.5 and 28.0 kg/m^2, both inclusive
  • Body weight of at least 60 kg.
  • Heart rate after 5 minutes rest in supine position inside the range of 50-90 beats/min at screening

Exclusion Criteria:

  • Any history of a disorder which in the investigator's opinion might jeopardize subjects safety, evaluation of results or compliance with the protocol.
  • History of gallbladder disease or cholecystectomy.
  • History of major depressive disorder or a Patient Health Questionnaire (PHQ-9) > 9 completed at screening, or a history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
  • Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to screening.
  • Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine position at screening, including a QTcF > 450 ms (males) or QTcF > 470 ms (females), PR ≥ 220 ms and QRS ≥ 110 ms as evaluated by the investigator.
  • History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction or contraindication to the use of Indocyanine Green (e.g. hypersensitivity to iodine).
  • Any clinically significant abnormal hematology, biochemistry, or urinalysis screening tests, as judged by the investigator.
  • TSH values outside of normal reference ranges of safety laboratory
  • Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2, as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
  • Known or suspected hypersensitivity to IMP(s) or related products.
  • Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).
  • Symptoms of arterial hypotension
  • Women of childbearing potential who are not using a highly effective contraceptive method
  • Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 28 days after dosing
  • Men with pregnant partner not willing to use male contraception (condom) until 28 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ZP7570
Single subcutaneous injection
Drug: Dual GLP-1/GLP-2 Receptor agonists
Eight ascending doses of ZP7570
Other Names:
  • ZP7570
Placebo Comparator: Placebo
Single subcutaneous injection
Drug: Dual GLP-1/GLP-2 Receptor agonists
Eight ascending doses of ZP7570
Other Names:
  • ZP7570

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety - Incidence of adverse events (AEs)
Time Frame: From time zero to 28 days after dosing
The incidence, type and severity of adverse events (AEs)
From time zero to 28 days after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Area under the plasma concentration-time curve trough
Time Frame: From time zero up to day 28
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
Time Frame: From time zero up to day 28
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
Time Frame: From time zero up to day 28
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
Time Frame: From time zero to 28 days after dosing
Measured maximum plasma drug concentration after dosing, Cmax
From time zero to 28 days after dosing
Pharmacokinetics - Time to maximum plasma concentration (Tmax)
Time Frame: From time zero to 28 days after dosing
Sampling time until reaching Cmax, Tmax
From time zero to 28 days after dosing
Pharmacokinetics - Half-life , t½
Time Frame: From time zero to 28 days after dosing
Half-life of ZP7570, t½
From time zero to 28 days after dosing
Pharmacokinetics - Volume of distribution
Time Frame: From time zero to 28 days after dosing
Apparent volume of distribution of ZP7570, Vz/f
From time zero to 28 days after dosing
Pharmacokinetics - Mean residence time
Time Frame: From time zero to 28 days after dosing
Mean residence time, MRT
From time zero to 28 days after dosing
Pharmacokinetics - Body clearance
Time Frame: From time zero to 28 days after dosing
Total body clearance, CL/f
From time zero to 28 days after dosing
Pharmacokinetics - Elimination rate constant
Time Frame: From time zero to 28 days after dosing
Elimination rate constant, λz
From time zero to 28 days after dosing
Pharmacodynamics - Plasma glucose levels
Time Frame: Time Frame: 0-240 minutes
Plasma glucose levels included with the acetaminophen at specific timepoints relative to a Mixed Test Meal
Time Frame: 0-240 minutes
Pharmacodynamics - Insulin concentrations
Time Frame: Time Frame: 0-240 minutes
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
Time Frame: Time Frame: 0-240 minutes
Plasma acetaminophen concentration-time curves following ingestion of acetaminophen
Time Frame: 0-240 minutes
Pharmacodynamics - Maximum acetaminophen concentration
Time Frame: Time Frame: 0-240 minutes
Change from baseline acetaminophen to maximum acetaminophen
Time Frame: 0-240 minutes
Pharmacodynamics - Time maximum acetaminophen concentration
Time Frame: Time Frame: 0-240 minutes
Time to maximum change in acetaminophen measure from baseline, Tmax
Time Frame: 0-240 minutes
Safety - Safety lab, haematology
Time Frame: From time zero to 28 days after dosing
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
Time Frame: From time zero to 28 days after dosing
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
Time Frame: From time zero to 28 days after dosing
Changes in urinalysis: Protein, Glucose Erythrocytes, Leucocytes, pH, ketones
From time zero to 28 days after dosing
Safety - Vital signs, blood pressure
Time Frame: From time zero to 28 days after dosing
Changes in vital signs, blood pressure (in mmHG)
From time zero to 28 days after dosing
Safety - Vital signs, pulse
Time Frame: From time zero to 28 days after dosing
Changes in pulse (beats per minute)
From time zero to 28 days after dosing
Safety - Physical examination
Time Frame: From time zero to 28 days after dosing
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
Time Frame: From time zero to 28 days after dosing
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
Time Frame: From time zero to 28 days after dosing
Occurrence of injection site reactions
From time zero to 28 days after dosing
Safety - Immunogenicity: Occurrence of anti-drug antibodies
Time Frame: From time zero to 28 days after dosing
Occurrence of anti-drug antibodies
From time zero to 28 days after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ulrike Hövelmann, MD, Profil Neuss, Germany

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZP7570-18144
  • 2019-001128-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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