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NCT Number: 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

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.

Recruiting

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, CL, 2333, Netherlands

Location status: Recruiting

Location contact

Jannik Rousel

CONTACT

[email protected]

+31 71 5246 400

Matthijs Moerland

PRINCIPAL_INVESTIGATOR

About this study

SAD Part A: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.

SAD Part B: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety, PK and PD will be assessed.

SAD Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed.

MAD Part: Participants will receive multiple doses of either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZP9830

Drug

SAD: 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

Drug

SAD: 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.

Primary outcomes

  1. Incident of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41)

    Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Information desk

CONTACT

[email protected]

+45 88 77 36 00

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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