Healthy VolunteersPhase 1NCT05794516
A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants
A Phase 1 study testing ZB004 in people with Healthy Volunteers, run by Zenas BioPharma (USA), LLC at 1 site in New Zealand.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ZB004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNew Zealand
- Study dates
- 19 Jun 2023to 21 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants 18 to 55 years of age.
- Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m^2 for both male and female participants.
- Considered in good health as determined by the Investigator.
- Female participants of child-bearing potential must agree to abstinence or use an highly effective form of contraception. Female participants must also refrain from donation of eggs from the signing of the informed consent to 6 months after receiving their dose of study drug.
- Male participants must be surgically sterile or agree to use effective contraception. Male participants must also agree not to donate sperm from the signing of the informed consent to 6 months after the last scheduled dose of the study drug.
- Willing and able to understand the characteristics and purposes of the study, including possible risks involved, and willing to comply with all the study requirements and provide written informed consent for the study.
Who cannot join
- Surgery within 4 weeks before Screening or planned surgery during the clinical study.
- Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins/dietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results.
- Clinically significant ECG abnormality.
- Positive for HIV, active hepatitis C or B, Covid-19 virus, tuberculosis.
- Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1.
- History of drug abuse in the previous 12 months before Screening, or positive for urine drug Screening (Day -28 to Day -1).
Show all 11Show fewer
- Donated blood (including component blood) or lost > 400 mL within 3 months before Screening or received a transfusion within 3 months of Screening.
- History of relevant allergies (including allergy to any murine or human-derived protein or immunoglobulin products, rubber or latex, or other allergies that in the opinion of the Investigator make inclusion in the study inappropriate).
- Average daily smoking > 10 cigarettes/day (or equivalent) within 6 months of Screening.
- Consume > 14 standard units of alcohol per week (1 standard unit is equivalent to approximately 360 mL of beer, 45 mL of spirits with 40% alcohol, or 150 mL of wine) or a positive alcohol breath test on Day -1.
- Any disease that might interfere with the safety evaluation of the investigational product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB004 in Healthy Volunteers
The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004.
Read the detailed description
Up to approximately 40 healthy volunteers across 5 cohorts randomized to receive ZB004 or placebo as single doses.
- Conditions
- Healthy Volunteers
- Being tested
- ZB004, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZB004Drug
ZB004 single doses administered subcutaneously as solution
PlaceboDrug
Placebo single doses administered subcutaneously as solution
| Study group | Role | What they receive |
|---|---|---|
| ZB004 | Experimental | Not described Receives: Drug: ZB004 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
Measured: Day 1 through Day 99
Secondary outcomes (10)
Number of participants with treatment-emergent serious adverse events (SAEs)
Measured: Day 1 through Day 99
Number of participants with laboratory abnormalities
Measured: Day 1 through Day 99
Number of participants with Electrocardiogram (ECG) abnormalities
Measured: Day 1 through Day 99
Maximum observed serum concentration (Cmax)
Measured: Day 1 through Day 99
Time for Cmax (Tmax)
Measured: Day 1 through Day 99
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Measured: Day 1 through Day 99
AUC from time 0 to the last quantifiable concentration (AUClast)
Measured: Day 1 through Day 99
Terminal half-life (t½)
Measured: Day 1 through Day 99
Apparent clearance following extravascular dosing (CL/F)
Measured: Day 1 through Day 99
Apparent volume of distribution following extravascular administration (Vz/F)
Measured: Day 1 through Day 99
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start19 Jun 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zenas BioPharma (USA), LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794516
- Sponsor's protocol ID
- ZB004-01-001
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB004 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05794516
- Acronym / sponsor ID
- ZB004-01-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zenas BioPharma (USA), LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 3 Apr 2023 (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 purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending doses of ZB004.
Detailed description
Up to approximately 40 healthy volunteers across 5 cohorts randomized to receive ZB004 or placebo as single doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZB004 | Experimental | Drug: ZB004 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female participants 18 to 55 years of age.
- Body weight ≥ 50 kg for male participants and ≥ 45 kg for female participants; body mass index of 18 to 35 kg/m^2 for both male and female participants.
- Considered in good health as determined by the Investigator.
- Female participants of child-bearing potential must agree to abstinence or use an highly effective form of contraception. Female participants must also refrain from donation of eggs from the signing of the informed consent to 6 months after receiving their dose of study drug.
- Male participants must be surgically sterile or agree to use effective contraception. Male participants must also agree not to donate sperm from the signing of the informed consent to 6 months after the last scheduled dose of the study drug.
Key exclusion criteria (11 listed)
- Surgery within 4 weeks before Screening or planned surgery during the clinical study.
- Use of prescription medications, biological products, or other medicines within 2 weeks before Study Day 1 or 5 half-lives of the product, whichever is greater. Use of over-the-counter medications or vitamins/dietary supplements within 7 days of dosing unless considered by the Investigator to not pose a risk or impact the study results.
- Clinically significant ECG abnormality.
- Positive for HIV, active hepatitis C or B, Covid-19 virus, tuberculosis.
- Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1.
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 |
|---|---|---|
| ZB004ZB004 single doses administered subcutaneously as solution | Drug | ZB004 |
| PlaceboPlacebo single doses administered subcutaneously as solution | Drug | Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
Time frame: Day 1 through Day 99
10 secondary outcomes
Number of participants with treatment-emergent serious adverse events (SAEs)
Time frame: Day 1 through Day 99
Number of participants with laboratory abnormalities
Time frame: Day 1 through Day 99
Number of participants with Electrocardiogram (ECG) abnormalities
Time frame: Day 1 through Day 99
Maximum observed serum concentration (Cmax)
Time frame: Day 1 through Day 99
Time for Cmax (Tmax)
Time frame: Day 1 through Day 99
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Time frame: Day 1 through Day 99
AUC from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 through Day 99
Terminal half-life (t½)
Time frame: Day 1 through Day 99
Apparent clearance following extravascular dosing (CL/F)
Time frame: Day 1 through Day 99
Apparent volume of distribution following extravascular administration (Vz/F)
Time frame: Day 1 through Day 99
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 ZB004 in people with Healthy Volunteers, run by Zenas BioPharma (USA), LLC at 1 site in New Zealand.
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 11 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: finished, as of the sponsor's last update on 13 Apr 2025. 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 New Zealand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004 (time frame: Day 1 through Day 99). 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 13 Apr 2025.