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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05794516




Registration number
NCT05794516
Ethics application status
Date submitted
20/03/2023
Date registered
3/04/2023
Date last updated
23/01/2024

Titles & IDs
Public title
A Safety and Pharmacokinetics Study of ZB004 in Healthy Participants
Scientific title
A Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB004 in Healthy Volunteers
Secondary ID [1] 0 0
ZB004-01-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZB004
Treatment: Drugs - Placebo

Experimental: ZB004 -

Placebo Comparator: Placebo -


Treatment: Drugs: ZB004
ZB004 single doses administered subcutaneously as solution

Treatment: Drugs: Placebo
Placebo single doses administered subcutaneously as solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events (TEAEs) to evaluate Safety and Tolerability of ZB004
Timepoint [1] 0 0
Day 1 through Day 99
Secondary outcome [1] 0 0
Number of participants with treatment-emergent serious adverse events (SAEs)
Timepoint [1] 0 0
Day 1 through Day 99
Secondary outcome [2] 0 0
Number of participants with laboratory abnormalities
Timepoint [2] 0 0
Day 1 through Day 99
Secondary outcome [3] 0 0
Number of participants with Electrocardiogram (ECG) abnormalities
Timepoint [3] 0 0
Day 1 through Day 99
Secondary outcome [4] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [4] 0 0
Day 1 through Day 99
Secondary outcome [5] 0 0
Time for Cmax (Tmax)
Timepoint [5] 0 0
Day 1 through Day 99
Secondary outcome [6] 0 0
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Timepoint [6] 0 0
Day 1 through Day 99
Secondary outcome [7] 0 0
AUC from time 0 to the last quantifiable concentration (AUClast)
Timepoint [7] 0 0
Day 1 through Day 99
Secondary outcome [8] 0 0
Terminal half-life (t½)
Timepoint [8] 0 0
Day 1 through Day 99
Secondary outcome [9] 0 0
Apparent clearance following extravascular dosing (CL/F)
Timepoint [9] 0 0
Day 1 through Day 99
Secondary outcome [10] 0 0
Apparent volume of distribution following extravascular administration (Vz/F)
Timepoint [10] 0 0
Day 1 through Day 99

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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).

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zenas BioPharma (USA), LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and pharmacokinetics of single-ascending
doses of ZB004.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05794516
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries