Centre for Human Drug Research
Leiden, CL, 2333, Netherlands
Location status: Recruiting
NCT Number: NCT06682975
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Leiden, CL, 2333, Netherlands
Location status: Recruiting
SAD Part A: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
SAD Part B: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety, PK and PD will be assessed.
SAD Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed.
MAD Part: Participants will receive multiple doses of either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41)
Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up
Contact information is provided by the study sponsor or research team.
Zealand Pharma
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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