A Phase 1 interventional study of ZP8396 and Placebo (ZP8396) in Overweight and Healthy Volunteers, sponsored by Zealand Pharma. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by Zealand Pharma · Phase 1, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 64 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment.
Drug: ZP8396
In each of the 10 single dose cohorts, 2 subjects will receive placebo.
Drug: Placebo (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.
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).
Incidence of treatment emergent adverse events (TEAEs)
Time frame: From dosing (Day 1) to end of trial (Day 50)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)
Time to maximum acetaminophen concentration after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])
Maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])
Time to maximum PG concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)
Maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)
Time to maximum insulin concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)
Maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)
Time to maximum glucagon concentration from 0 to 240 minutes after ingestion of a standardised Mixed Test Meal (MTM) and 1000 mg acetaminophen
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)
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
Time frame: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zealand Pharma