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Completed

NCT Number: NCT05096598

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

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.

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Key information

Conditions

Overweight Body Weight Healthy Volunteers Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZP8396

Drug

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 (ZP8396)

Drug

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).

Primary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: From dosing (Day 1) to end of trial (Day 50)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2021
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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