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.
Healthy participants.
18-45 years of age (inclusive).
Body weight ≥50 kg.
SAD part B only: Fitzpatrick skin type I-III (Caucasian).
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.
Sequential
ZP9830
DrugSAD: 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
DrugSAD: 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.
Incident of Treatment Emergent Adverse Events (TEAEs)
Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up
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