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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05638854




Registration number
NCT05638854
Ethics application status
Date submitted
15/11/2022
Date registered
6/12/2022
Date last updated
26/09/2024

Titles & IDs
Public title
A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants with Rheumatoid Arthritis
Scientific title
A Phase 1, 2-Part, Single Ascending Dose (SAD) Study to Evaluate the Safety and Pharmacokinetics (PK) of ZB002 in Healthy Volunteers (HVs) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety and PK of ZB002 in Participants with Rheumatoid Arthritis (RA)
Secondary ID [1] 0 0
ZB002-01-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZB002
Treatment: Drugs - Placebo
Treatment: Drugs - ZB002
Treatment: Drugs - Placebo

Experimental: Part A: SAD in Healthy Volunteers - Healthy volunteers will receive a single dose of ZB002 or placebo

Experimental: Part B: MAD in RA Participants - RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations


Treatment: Drugs: ZB002
ZB002 will be administered subcutaneously as per schedule specified in the respective arm.

Treatment: Drugs: Placebo
Placebo will be administered subcutaneously as per schedule specified in the respective arm.

Treatment: Drugs: ZB002
ZB002 will be administered subcutaneously as per schedule specified in the respective arm.

Treatment: Drugs: Placebo
Placebo will be administered subcutaneously as per schedule specified in the respective arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Safety and Tolerability in HVs
Timepoint [1] 0 0
Day 1 through Day 120
Primary outcome [2] 0 0
Part B: Safety and Tolerability of multiple doses of ZB002 in participants with RA
Timepoint [2] 0 0
Day 1 through Day 176
Secondary outcome [1] 0 0
Part A: Maximum observed serum concentration (Cmax)
Timepoint [1] 0 0
Day 1 through Day 120
Secondary outcome [2] 0 0
Part A: Time for Cmax (Tmax)
Timepoint [2] 0 0
Day 1 through Day 120
Secondary outcome [3] 0 0
Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Timepoint [3] 0 0
Day 1 through Day 120
Secondary outcome [4] 0 0
Part A: AUC from time 0 to the last quantifiable concentration (AUClast)
Timepoint [4] 0 0
Day 1 through Day 120
Secondary outcome [5] 0 0
Part A: Terminal half-life (t1/2)
Timepoint [5] 0 0
Day 1 through Day 120
Secondary outcome [6] 0 0
Part A: Apparent clearance following extravascular dosing (CL/F)
Timepoint [6] 0 0
Day 1 through Day 120
Secondary outcome [7] 0 0
Part A: Apparent volume of distribution following extravascular administration (Vz/F)
Timepoint [7] 0 0
Day 1 through Day 120
Secondary outcome [8] 0 0
Part B (All Doses): Serum trough concentration (Ctrough)
Timepoint [8] 0 0
Day 1 through Day 176
Secondary outcome [9] 0 0
Part B (Doses 1 and 3): Maximum observed serum concentration (Cmax)
Timepoint [9] 0 0
Day 1 through Day 176
Secondary outcome [10] 0 0
Part B (Doses 1 and 3): Time for Cmax (Tmax)
Timepoint [10] 0 0
Day 1 through Day 176
Secondary outcome [11] 0 0
Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau)
Timepoint [11] 0 0
Day 1 through Day 176
Secondary outcome [12] 0 0
Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax)
Timepoint [12] 0 0
Day 1 through Day 176
Secondary outcome [13] 0 0
Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC)
Timepoint [13] 0 0
Day 1 through Day 176
Secondary outcome [14] 0 0
Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Timepoint [14] 0 0
Day 1 through Day 176
Secondary outcome [15] 0 0
Part B (Dose 3 only): Terminal half-life (t1/2)
Timepoint [15] 0 0
Day 1 through Day 176
Secondary outcome [16] 0 0
Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast)
Timepoint [16] 0 0
Day 1 through Day 176
Secondary outcome [17] 0 0
Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F)
Timepoint [17] 0 0
Day 1 through Day 176
Secondary outcome [18] 0 0
Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F)
Timepoint [18] 0 0
Day 1 through Day 176
Secondary outcome [19] 0 0
Part B: Serum anti-ZB002 antibody prevalence and incidence
Timepoint [19] 0 0
Day 1 through Day 176
Secondary outcome [20] 0 0
Part B: Cytokine/chemokine secretion in ex vivo stimulated whole blood
Timepoint [20] 0 0
Day 1 through Day 176

Eligibility
Key inclusion criteria
Main Inclusion Criteria

Part A SAD (HV):

* 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 effective form of contraception.
* Male participants must be surgically sterile or agree to use effective contraception.
* 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.

Part B MAD (RA Participants):

* Male or female participants 18 to 70 years (inclusive) of age at Screening.
* Body mass index of = 18.0 and = 40.0 kg/m2.
* Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA = 3 months before Screening.
* Use of methotrexate at 7.5 to 25 mg/week for = 3 months, with stable dosing for = 4 weeks, before randomization. Hydroxychloroquine/chloroquine and/or sulfasalazine are allowed if started = 3 months before randomization and a stable dose is maintained after the Screening Visit.

Main
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

Part A SAD (HV):

* 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.
* Treatment with any investigational drug within 30 days or 5 half-lives, whichever is greater, before the first dose of the study drug, or currently enrolled in another clinical study.
* Clinically significant ECG abnormality.
* Positive for HIV infection, active hepatitis C, or hepatitis B.
* Positive for COVID-19 virus.
* Positive QuantiFERON®-TB Gold or T-SPOT® test for Mycobacterium tuberculosis.
* Bacteria, viruses, systemic fungi, parasites, or other opportunistic infections within 30 days before Study Day 1.
* Documented history of drug abuse in the previous 12 months before Screening, or positive for urine drug screen on Screening and/or 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 or cigarette equivalents per day 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.

Part B MAD (RA Participants):

* Inflammatory joint disease other than RA. Note: Current diagnosis of secondary Sjogren's Syndrome is permitted.
* Surgery within 4 weeks before Screening or planned surgery during the clinical study.
* History of any malignancy within 5 years, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.
* Documented history of drug abuse in the previous 12 months before Screening (Days -28 to -1), or positive for urine drug screen for nonprescribed drugs other than cannabinoid at Screening.
* Any condition considered by the investigator to make participation in the study inappropriate.
* Donated blood (including component blood) or lost > 400 mL within 1 month before Screening or received a transfusion within 3 months of Screening.
* After the Screening Visit, corticosteroid use > 10 mg/day (prednisone equivalent) or increase in dose
* Positive for HIV infection, active hepatitis C, or hepatitis B.
* Test positive for Mycobacterium tuberculosis.
* Bacterial, viral, systemic fungal, parasitic, or opportunistic infection not resolved at least 14 days before Study Day 1 or expected to be treated with antibiotics during the Treatment Period, or history of recurrent infections.
* Employees or related personnel of the study site, the sponsor, or contract research organization.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Veritus Research - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
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
Trial website
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
Cory D Sellwood, MBChB
Address 0 0
Country 0 0
Phone 0 0
+6433729477
Fax 0 0
Email 0 0
cory.sellwood@nzcr.co.nz
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05638854