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Recruiting Phase 1 NCT06682975

A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants

Trial Parameters

Condition Healthy Volunteers
Sponsor Zealand Pharma
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 124
Sex ALL
Min Age 18 Years
Max Age 45 Years
Start Date 2024-11-12
Completion 2026-08
Interventions
ZP9830Placebo

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Healthy participants. * 18-45 years of age (inclusive). * Body weight ≥50 kg. * SAD part B only: Fitzpatrick skin type I-III (Caucasian). * C-reactive protein ≤10 mg/L. * Further inclusion criteria apply. Exclusion Criteria: * Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of it might interfere with, the conduct or the interpretation of the results of the trial, or that would pose an unacceptable risk to the subject in the opinion of the Investigator \[following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead ECG\]. * Any disease associated with immune system impairment, including immune mediated diseases and transplantation patients. * Any confirmed significant allergic reactions (urticaria or anaphylaxis) to insect bites. * History of neurological disorders including neuropathy, as judged by the investigato

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