๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Healthy participants.
* 18-45 years of age (inclusive).
* Body weight โฅ50 kg.
* SAD part B only: Fitzpatrick skin type I-III (Caucasian).
* C-reactive protein โค10 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 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).
* Further exclusion criteria apply.
Centre for Human Drug Research
Leiden, Netherlands
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.