A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants

NCT06682975 | Recruiting Phase 1

• 4 other identifiers: ZP9830-230052023-509929-51-002023-509929-51U1111-1305-8892
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incident of Treatment Emergent Adverse Events (TEAEs)

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

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

Study Arms (2)

ZP9830

EXPERIMENTAL

Up to 10 SAD cohorts planned: Part A, 3 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830. Part B, 6 cohorts of each 10 participants with 8 participants receiving s.c. active treatment of ZP9830. Part C, 1 cohort of 8 participants with 6 participants receiving i.v. active treatment of ZP9830 Up to 4 MAD cohorts planned: 4 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830.

Drug: ZP9830

Placebo

PLACEBO COMPARATOR

SAD: In each of the 10 single dose cohorts, 2 subjects will receive placebo MAD: In each of the 4 multiple dose cohorts, 2 subjects will receive placebo

Drug: Placebo

Interventions

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.

ZP9830

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants.
• years of age (inclusive).
• Body weight ≥50 kg.
• SAD part B only: Fitzpatrick skin type I-III (Caucasian).
• C-reactive protein ≤10 mg/L.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zealand Pharma: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, CL, 2333, Netherlands

RECRUITING

Study Officials

• Zealand Pharma A/S

  Zealand Pharma A/S

  STUDY DIRECTOR

Central Study Contacts

Clinical Trial Information desk

CONTACT

+45 88 77 36 00; clinicaltrials@zealandpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel (active or placebo), sequential (dose escalation)

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)