A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants
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.
Zealand Pharma
124 participants
Nov 12, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Healthy participants.
- -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.
Exclusion Criteria5
- 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 investigator.
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food (in particular any level of severity of allergy to shellfish), or multiple drug allergies (non-active hay fever is acceptable).
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06682975