NCT06682975 A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants
| NCT ID | NCT06682975 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Zealand Pharma |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 124 participants in total. It began in 2024-11-12 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Zealand Pharma A/S
STUDY DIRECTOR
Zealand Pharma A/S
Frequently Asked Questions
Who can join the NCT06682975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06682975 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06682975 currently recruiting?
Yes, NCT06682975 is actively recruiting participants. Contact the research team at clinicaltrials@zealandpharma.com for enrollment information.
Where is the NCT06682975 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06682975 clinical trial?
NCT06682975 is sponsored by Zealand Pharma. The principal investigator is Zealand Pharma A/S at Zealand Pharma A/S. The trial plans to enroll 124 participants.