NCT05096598

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Zealand Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight
• Healthy Volunteers

Interventions

Type	Name	Description
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.
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

• Start date: 2021-10-19
• Primary completion: 2023-01-12
• Completion: 2023-01-12
• First posted: 2021-10-27
• Last updated: 2023-01-17

Locations

1 site across 1 country: Germany