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
Official title: A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Healthy Volunteers
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: First human dose trial. A single-centre, placebo-controlled, double-blind (within cohorts), randomised single dose trial.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: From dosing (Day 1) to end of trial (Day 50)
Secondary outcomes:
measure: Pharmacokinetics (PK) of ZP8396 (AUCτ)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (AUCinf)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (AUClast)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (Cmax)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (tmax)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (λz)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (t½)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (Vz/f)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (Vz)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (CL/f)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (CL)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacokinetics (PK) of ZP8396 (MRT)
timeFrame: Day 1 (pre-dose) to Day 50 (1176 hours post-dose)
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
measure: Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)
timeFrame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
state: North Rhine-Westphalia
Study officials:
affiliation: Zealand Pharma A/S
name: Zealand Pharma A/S
role: STUDY_DIRECTOR
References: