Investigating the safety of ZP9830 in 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.
This study is testing the safety of a new drug called ZP9830 in healthy people to see how it works in the body compared to a placebo.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Zealand Pharma Industry-sponsored |
| Locations | 1 site (Leiden, CL) |
| Trial ID | NCT06682975 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male participants aged 18-45 with a body weight of at least 50 kg.
Not a fit: Patients with active or chronic diseases, immune system impairments, or significant allergic reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of ZP9830's safety profile, paving the way for its use in treating autoimmune diseases.
How similar studies have performed: While this study is focused on a specific drug, similar studies assessing the safety of new treatments in healthy participants have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Leiden, CL
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.