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

NCT05638854 | Recruiting Phase 1

• 1 other identifier: ZB002-01-001
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

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.

Conditions

Healthy Volunteers; Rheumatoid Arthritis

Keywords

Healthy Volunteers; Healthy Subjects; Healthy Participants; Patients; Rheumatoid Arthritis; RA

Outcome Measures

Primary Outcomes (2)

• Part A: Safety and Tolerability in HVs

  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)

  Day 1 through Day 120

• Part B: Safety and Tolerability of multiple doses of ZB002 in participants with RA

  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

  Day 1 through Day 176

Secondary Outcomes (20)

• Part A: Maximum observed serum concentration (Cmax)

  Day 1 through Day 120

• Part A: Time for Cmax (Tmax)

  Day 1 through Day 120

• Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

  Day 1 through Day 120

• Part A: AUC from time 0 to the last quantifiable concentration (AUClast)

  Day 1 through Day 120

• Part A: Terminal half-life (t1/2)

  Day 1 through Day 120

Study Arms (2)

Part A: SAD in Healthy Volunteers

EXPERIMENTAL

Healthy volunteers will receive a single dose of ZB002 or placebo

Drug: ZB002; Drug: Placebo

Part B: MAD in RA Participants

EXPERIMENTAL

RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations

Drug: ZB002; Drug: Placebo

Interventions

ZB002 DRUG

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

Part A: SAD in Healthy Volunteers

Placebo DRUG

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

Part A: SAD in Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zenas BioPharma (USA), LLC: lead

Study Sites (2)

Veritus Research

Melbourne, Australia

NOT YET RECRUITING

NZCR New Zealand Clinical Research

Christchurch, New Zealand

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Cory D Sellwood, MBChB

CONTACT

+6433729477; cory.sellwood@nzcr.co.nz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 6, 2022
• Study Start: December 8, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

NZ (1); AU (1)