Investigating the safety of ZP9830 in healthy participants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research focuses on assessing the safety and tolerability of ZP9830 in healthy individuals. The study is divided into three parts: participants will receive either ZP9830 or a placebo via subcutaneous or intravenous injection. The primary objectives include evaluating the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the effects of the drug) compared to a placebo. Safety assessments will be conducted throughout the study to ensure participant well-being.

Why it matters

Who can join: the full rules

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 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.

Where it's running

• Centre for Human Drug Research
  Leiden, Cl, Netherlands Recruiting

Study contacts

• Study coordinator: Clinical Trial Information desk
• Email: clinicaltrials@zealandpharma.com
• Phone: +45 88 77 36 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.