- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05096598
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).
Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Rhine-Westphalia
-
Neuss, North Rhine-Westphalia, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male subject
- Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
- Body weight of at least 70.0 kg
- Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent
- Further inclusion criteria apply
Exclusion Criteria:
- History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
- Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg
- Symptoms of arterial hypotension
- Further exclusion criteria apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ZP8396
Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment.
|
Participants will receive 1 single dose of ZP8396 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm).
Dose level will depend on the cohort.
|
Placebo Comparator: Placebo (ZP8396)
In each of the 10 single dose cohorts, 2 subjects will receive placebo.
|
Participants will receive 1 single dose of placebo given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: From dosing (Day 1) to end of trial (Day 50)
|
From dosing (Day 1) to end of trial (Day 50)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) of ZP8396 (AUCτ)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Area under the plasma concentration-time curve over a dosing interval
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (AUCinf)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Area under the plasma concentration-time curve from time zero to infinity
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (AUClast)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (Cmax)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Maximum (peak) plasma drug concentration
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (tmax)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Time to reach maximum (peak) plasma concentration
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (λz)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Elimination rate constant
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (t½)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Elimination half-life
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (Vz/f)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Apparent volume of distribution during terminal phase
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (Vz)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Volume of distribution during the terminal phase (i.v.
only)
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (CL/f)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Apparent total clearance of the drug from plasma
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (CL)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Total body clearance of the drug (i.v.
only)
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacokinetics (PK) of ZP8396 (MRT)
Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Mean residence time
|
Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the acetaminophen concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the acetaminophen concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the Plasma Glucose (PG) concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the Plasma Glucose (PG) concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Time to maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the insulin concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the insulin concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Time to maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the glucagon concentration-time curve from 0 to 60 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)
Time Frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Area under the glucagon concentration-time curve from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
|
0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zealand Pharma A/S, Zealand Pharma A/S
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZP8396-21037
- 2021-001712-28 (EudraCT Number)
- U1111-1267-1489 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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