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

Zealand Pharma64 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overweight Healthy Volunteers

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of treatment emergent adverse events (TEAEs)

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

Secondary Outcomes

Pharmacokinetics (PK) of ZP8396 (AUCτ)

Area under the plasma concentration-time curve over a dosing interval

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (AUCinf)

Area under the plasma concentration-time curve from time zero to infinity

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (AUClast)

Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (Cmax)

Maximum (peak) plasma drug concentration

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (tmax)

Time to reach maximum (peak) plasma concentration

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (λz)

Elimination rate constant

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (t½)

Elimination half-life

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (Vz/f)

Apparent volume of distribution during terminal phase

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (Vz)

Volume of distribution during the terminal phase (i.v. only)

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (CL/f)

Apparent total clearance of the drug from plasma

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (CL)

Total body clearance of the drug (i.v. only)

Time frame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)

Pharmacokinetics (PK) of ZP8396 (MRT)

Mean residence time

Time frame: 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)

Maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen