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A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants with Rheumatoid Arthritis

PHASE1RECRUITING

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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Study details:

Part A (SAD): Up to approximately 48 healthy volunteers across 6 cohorts randomized to receive ZB002 or placebo as a single dose. Part B (MAD): Up to approximately 24 participants with RA across 3 cohorts randomized to receive ZB002 or placebo as multiple doses.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 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.
  • 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.
  • 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.
  • 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.
  • 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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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : Yes

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-12-08

    Primary completion: 2025-07-01

    Study completion finish: 2025-07-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05638854

    Intervention or treatment

    DRUG: ZB002

    DRUG: Placebo

    DRUG: ZB002

    DRUG: Placebo

    Conditions

    • Healthy Volunteers
    • Rheumatoid Arthritis

    Find a site

    Closest Location:

    Veritus Research

    Research sites nearby

    Select from list below to view details:

    • Veritus Research

      Melbourne, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Part A: SAD in Healthy Volunteers
    • Healthy volunteers will receive a single dose of ZB002 or placebo
    DRUG: ZB002
    • ZB002 will be administered subcutaneously as per schedule specified in the respective arm.
    EXPERIMENTAL: Part B: MAD in RA Participants
    • RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations
    DRUG: ZB002
    • ZB002 will be administered subcutaneously as per schedule specified in the respective arm.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Part A: Safety and Tolerability in HVsTo 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)Day 1 through Day 120
    Part B: Safety and Tolerability of multiple doses of ZB002 in participants with RATo 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 discontinuationDay 1 through Day 176

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Part A: Maximum observed serum concentration (Cmax)PharmacokineticsDay 1 through Day 120
    Part A: Time for Cmax (Tmax)PharmacokineticsDay 1 through Day 120
    Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)PharmacokineticsDay 1 through Day 120
    Part A: AUC from time 0 to the last quantifiable concentration (AUClast)PharmacokineticsDay 1 through Day 120
    Part A: Terminal half-life (t1/2)PharmacokineticsDay 1 through Day 120
    Part A: Apparent clearance following extravascular dosing (CL/F)PharmacokineticsDay 1 through Day 120
    Part A: Apparent volume of distribution following extravascular administration (Vz/F)PharmacokineticsDay 1 through Day 120
    Part B (All Doses): Serum trough concentration (Ctrough)Before repeat-dose administration (or at the end of the dosing interval \[tau\] after the final dose)Day 1 through Day 176
    Part B (Doses 1 and 3): Maximum observed serum concentration (Cmax)PharmacokineticsDay 1 through Day 176
    Part B (Doses 1 and 3): Time for Cmax (Tmax)PharmacokineticsDay 1 through Day 176
    Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau)PharmacokineticsDay 1 through Day 176
    Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax)PharmacokineticsDay 1 through Day 176
    Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC)PharmacokineticsDay 1 through Day 176
    Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)PharmacokineticsDay 1 through Day 176
    Part B (Dose 3 only): Terminal half-life (t1/2)PharmacokineticsDay 1 through Day 176
    Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast)PharmacokineticsDay 1 through Day 176
    Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F)PharmacokineticsDay 1 through Day 176
    Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F)PharmacokineticsDay 1 through Day 176
    Part B: Serum anti-ZB002 antibody prevalence and incidenceNot SpecifiedDay 1 through Day 176
    Part B: Cytokine/chemokine secretion in ex vivo stimulated whole bloodPharmacodynamicDay 1 through Day 176

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants with Rheumatoid Arthritis

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