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RecruitingNCT06682975Updated Feb 17, 2026

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

A Phase 1 interventional study of ZP9830 and Placebo in Healthy Volunteers, sponsored by Zealand Pharma. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Zealand Pharma · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Zealand Pharma is the lead sponsor of 43 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 8 (47%) have results posted.

Browse Zealand Pharma studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ].
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    ZP9830

    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 comparator
    Placebo

    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

  • DrugZP9830

    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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Incident of Treatment Emergent Adverse Events (TEAEs)

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06682975
Lead sponsor
Zealand Pharma
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Nov 12, 2024
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Feb 17, 2026

Study contacts

Clinical Trial Information desk
Contact
clinicaltrials@zealandpharma.com
+45 88 77 36 00
Zealand Pharma A/S
study director · Zealand Pharma A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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