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A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants
Sponsor: Zealand Pharma
Summary
The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.
Official title: A First-in-human, Randomized and Double-blind Within Cohorts, Placebo-controlled, Single and Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP9830 Administered to Healthy Participants.
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2024-11-12
Completion Date
2026-08
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
ZP9830
SAD: Participants will receive 1 single dose of ZP9830 given subcutaneously (s.c., under the skin) or intravenously (i.v., in a vein of the arm). Dose level will depend on the cohort. MAD: Participants will receive multiple doses of ZP9830 given subcutaneously (s.c., under the skin). Dose level will depend on the cohort.
Placebo
SAD: 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). Volume will be matching the active treatment. MAD: Participants will receive multiple doses of placebo given subcutaneously (s.c., under the skin). Volume will be matching the active treatment.
Locations (1)
Centre for Human Drug Research
Leiden, CL, Netherlands