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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/NCT05638854
Registration number
NCT05638854
Ethics application status
Date submitted
15/11/2022
Date registered
6/12/2022
Date last updated
7/03/2024
Titles & IDs
Public title
A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants With Rheumatoid Arthritis
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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)
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Secondary ID [1]
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ZB002-01-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Safety and Tolerability in HVs
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Assessment method [1]
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To evaluate the safety and tolerability of ZB002 in HVs by assessing the number, severity and type of adverse events, including changes in laboratory safety test and electrocardiogram (ECG)
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Timepoint [1]
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Day 1 through Day 120
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Primary outcome [2]
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Part B: Safety and Tolerability of multiple doses of ZB002 in participants with RA
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Assessment method [2]
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To evaluate the safety and tolerability of ZB002 in participants with RA by assessing the number of participants with Treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAE leading to discontinuation
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Timepoint [2]
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Day 1 through Day 176
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Secondary outcome [1]
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Part A: Maximum observed serum concentration (Cmax)
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Assessment method [1]
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Pharmacokinetics
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Timepoint [1]
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Day 1 through Day 120
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Secondary outcome [2]
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Part A: Time for Cmax (Tmax)
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Assessment method [2]
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Pharmacokinetics
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Timepoint [2]
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Day 1 through Day 120
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Secondary outcome [3]
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Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
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Assessment method [3]
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Pharmacokinetics
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Timepoint [3]
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Day 1 through Day 120
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Secondary outcome [4]
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Part A: AUC from time 0 to the last quantifiable concentration (AUClast)
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Assessment method [4]
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Pharmacokinetics
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Timepoint [4]
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Day 1 through Day 120
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Secondary outcome [5]
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Part A: Terminal half-life (t1/2)
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Assessment method [5]
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Pharmacokinetics
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Timepoint [5]
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Day 1 through Day 120
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Secondary outcome [6]
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Part A: Apparent clearance following extravascular dosing (CL/F)
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Assessment method [6]
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Pharmacokinetics
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Timepoint [6]
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Day 1 through Day 120
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Secondary outcome [7]
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Part A: Apparent volume of distribution following extravascular administration (Vz/F)
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Assessment method [7]
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Pharmacokinetics
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Timepoint [7]
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Day 1 through Day 120
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Secondary outcome [8]
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Part B (All Doses): Serum trough concentration (Ctrough)
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Assessment method [8]
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Before repeat-dose administration (or at the end of the dosing interval [tau] after the final dose)
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Timepoint [8]
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Day 1 through Day 176
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Secondary outcome [9]
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Part B (Doses 1 and 3): Maximum observed serum concentration (Cmax)
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Assessment method [9]
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Pharmacokinetics
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Timepoint [9]
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Day 1 through Day 176
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Secondary outcome [10]
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Part B (Doses 1 and 3): Time for Cmax (Tmax)
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Assessment method [10]
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Pharmacokinetics
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Timepoint [10]
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Day 1 through Day 176
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Secondary outcome [11]
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Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau)
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Assessment method [11]
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Pharmacokinetics
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Timepoint [11]
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Day 1 through Day 176
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Secondary outcome [12]
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Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax)
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Assessment method [12]
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Pharmacokinetics
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Timepoint [12]
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Day 1 through Day 176
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Secondary outcome [13]
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Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC)
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Assessment method [13]
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Pharmacokinetics
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Timepoint [13]
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Day 1 through Day 176
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Secondary outcome [14]
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Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
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Assessment method [14]
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Pharmacokinetics
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Timepoint [14]
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Day 1 through Day 176
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Secondary outcome [15]
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Part B (Dose 3 only): Terminal half-life (t1/2)
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Assessment method [15]
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Pharmacokinetics
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Timepoint [15]
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Day 1 through Day 176
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Secondary outcome [16]
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Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast)
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Assessment method [16]
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Pharmacokinetics
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Timepoint [16]
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Day 1 through Day 176
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Secondary outcome [17]
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Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F)
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Assessment method [17]
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Pharmacokinetics
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Timepoint [17]
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Day 1 through Day 176
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Secondary outcome [18]
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Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F)
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Assessment method [18]
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Pharmacokinetics
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Timepoint [18]
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Day 1 through Day 176
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Secondary outcome [19]
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Part B: Serum anti-ZB002 antibody prevalence and incidence
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Assessment method [19]
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Timepoint [19]
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Day 1 through Day 176
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Secondary outcome [20]
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Part B: Cytokine/chemokine secretion in ex vivo stimulated whole blood
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Assessment method [20]
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Pharmacodynamic
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Timepoint [20]
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Day 1 through Day 176
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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.
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Minimum age
18
Years
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/12/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Veritus Research - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Zenas BioPharma (USA), LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This double-blind, randomized, placebo-controlled study will assess the safety and
pharmacokinetics of ZB002 in healthy participants and in participants with rheumatoid
arthritis (RA). The study consists of 2 parts. Part A: Single Ascending Dose (SAD), which
will include only healthy volunteers. Part B: Multiple Ascending Dose (MAD), will commence
after completion of the SAD study and will include RA participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05638854
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05638854
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