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.
A First-in-human Study Looking at the Safety of ZP8396 and How it Works in the Body of Healthy Trial Participants
Status
Completed
Phase
Phase 1
Enrollment
64
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
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).
Timeline
From registration to results.
First posted
Oct 27, 2021
Study start
Oct 19, 2021
Primary completion
Jan 12, 2023
Study completion
Jan 12, 2023
Results posted
Not reported
Registry updated
Jan 17, 2023
Outcomes
What the study measures.
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)
Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Area under the plasma concentration-time curve over a dosing interval
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
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
Pharmacokinetics (PK) of ZP8396 (Cmax)
Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Maximum (peak) plasma drug concentration
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
Pharmacokinetics (PK) of ZP8396 (λz)
Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Elimination rate constant
Pharmacokinetics (PK) of ZP8396 (t½)
Time frame · Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
Elimination half-life
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
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)
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- MALE
- Healthy volunteers
- Yes
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 locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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