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A Randomized, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of ZP8396 or placebo
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). The trial is divided in two parts: Part 1: 20 Participants will receive 6 once-weekly doses as an injection under the skin (subcutaneous, s.c.). Participants will have 14 visits with the study team. 6 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 116 days. Part 2: 48 Participants will receive 16 once-weekly doses as an injection under the skin (subcutaneous, s.c.) in a dose up-titration dose scheme. Participants will have 23 or 24 visits with the study team. 13 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 198 days.
Age
18 - 64 years
Sex
ALL
Healthy Volunteers
Yes
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, Germany
Start Date
November 7, 2022
Primary Completion Date
June 13, 2024
Completion Date
June 13, 2024
Last Updated
June 18, 2024
68
ACTUAL participants
ZP8396
DRUG
Drug: Placebo (ZP8396)
DRUG
Lead Sponsor
Zealand Pharma
NCT07472881
NCT07310264
Data Source & Attribution
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