Healthy VolunteersPhase 1NCT06682975
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 study testing ZP9830 in people with Healthy Volunteers, run by Zealand Pharma at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ZP9830
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Nov 2024to Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Centre for Human Drug Research
Leiden, CL, 2333
Jannik Rousel, +31 71 5246 400, info@chdr.nl
Matthijs Moerland
About this study
Official 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.
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.
- Conditions
- Healthy Volunteers
- Being tested
- ZP9830, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZP9830Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of Treatment Emergent Adverse Events (TEAEs)
Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up
Measured: From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start12 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Parallel (active or placebo), sequential (dose escalation)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zealand Pharma A/S, Study director, Zealand Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682975
- Sponsor's protocol ID
- ZP9830-23005
- Other IDs
- 2023-509929-51-00, 2023-509929-51, U1111-1305-8892, 2023
- Status last verified
- Feb 2026
- First submitted
- 7 Nov 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06682975
- Acronym / sponsor ID
- ZP9830-23005
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Zealand PharmaIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel (active or placebo), sequential (dose escalation)
| Arm | Type | Receives |
|---|---|---|
| ZP9830 | Experimental | Drug: ZP9830Up 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. |
| Placebo | Placebo comparator | Drug: PlaceboSAD: 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZP9830SAD: 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. | Drug | ZP9830 |
| PlaceboSAD: 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. | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zealand Pharma A/S study director
Zealand Pharma A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ZP9830 in people with Healthy Volunteers, run by Zealand Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Information desk (+45 88 77 36 00, clinicaltrials@zealandpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of Treatment Emergent Adverse Events (TEAEs) (time frame: From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.