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A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05096598
Recruitment Status : Completed
First Posted : October 27, 2021
Last Update Posted : January 17, 2023
Sponsor:
Information provided by (Responsible Party):
Zealand Pharma

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Overweight Healthy Volunteers Drug: ZP8396 Drug: Placebo (ZP8396) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
Actual Study Start Date : October 19, 2021
Actual Primary Completion Date : January 12, 2023
Actual Study Completion Date : January 12, 2023
Arms and Interventions
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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.
 Drug: ZP8396
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.
 Drug: Placebo (ZP8396)
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).


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: From dosing (Day 1) to end of trial (Day 50) ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Pharmacokinetics (PK) of ZP8396 (Cmax) [ Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose) ]
    Maximum (peak) plasma drug concentration

  5. 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

  6. Pharmacokinetics (PK) of ZP8396 (λz) [ Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose) ]
    Elimination rate constant

  7. Pharmacokinetics (PK) of ZP8396 (t½) [ Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose) ]
    Elimination half-life

  8. 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

  9. 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)

  10. 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

  11. 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)

  12. Pharmacokinetics (PK) of ZP8396 (MRT) [ Time Frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose) ]
    Mean residence time

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05096598


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany, 41460
Sponsors and Collaborators
Zealand Pharma
Investigators
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Study Director: Zealand Pharma A/S Zealand Pharma A/S
More Information
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Responsible Party: Zealand Pharma
ClinicalTrials.gov Identifier: NCT05096598    
Other Study ID Numbers: ZP8396-21037
2021-001712-28 ( EudraCT Number )
U1111-1267-1489 ( Other Identifier: WHO )
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: January 17, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight