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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]

ZB002-01-001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Healthy Volunteers

Rheumatoid Arthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Inflammatory and Immune System

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part A: Safety and Tolerability in HVs

Timepoint [1]

Day 1 through Day 120

Primary outcome [2]

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

Timepoint [2]

Day 1 through Day 176

Secondary outcome [1]

Part A: Maximum observed serum concentration (Cmax)

Timepoint [1]

Day 1 through Day 120

Secondary outcome [2]

Part A: Time for Cmax (Tmax)

Timepoint [2]

Day 1 through Day 120

Secondary outcome [3]

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

Timepoint [3]

Day 1 through Day 120

Secondary outcome [4]

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

Timepoint [4]

Day 1 through Day 120

Secondary outcome [5]

Part A: Terminal half-life (t1/2)

Timepoint [5]

Day 1 through Day 120

Secondary outcome [6]

Part A: Apparent clearance following extravascular dosing (CL/F)

Timepoint [6]

Day 1 through Day 120

Secondary outcome [7]

Part A: Apparent volume of distribution following extravascular administration (Vz/F)

Timepoint [7]

Day 1 through Day 120

Secondary outcome [8]

Part B (All Doses): Serum trough concentration (Ctrough)

Timepoint [8]

Day 1 through Day 176

Secondary outcome [9]

Part B (Doses 1 and 3): Maximum observed serum concentration (Cmax)

Timepoint [9]

Day 1 through Day 176

Secondary outcome [10]

Part B (Doses 1 and 3): Time for Cmax (Tmax)

Timepoint [10]

Day 1 through Day 176

Secondary outcome [11]

Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau)

Timepoint [11]

Day 1 through Day 176

Secondary outcome [12]

Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax)

Timepoint [12]

Day 1 through Day 176

Secondary outcome [13]

Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC)

Timepoint [13]

Day 1 through Day 176

Secondary outcome [14]

Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)

Timepoint [14]

Day 1 through Day 176

Secondary outcome [15]

Part B (Dose 3 only): Terminal half-life (t1/2)

Timepoint [15]

Day 1 through Day 176

Secondary outcome [16]

Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast)

Timepoint [16]

Day 1 through Day 176

Secondary outcome [17]

Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F)

Timepoint [17]

Day 1 through Day 176

Secondary outcome [18]

Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F)

Timepoint [18]

Day 1 through Day 176

Secondary outcome [19]

Part B: Serum anti-ZB002 antibody prevalence and incidence

Timepoint [19]

Day 1 through Day 176

Secondary outcome [20]

Part B: Cytokine/chemokine secretion in ex vivo stimulated whole blood

Timepoint [20]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Veritus Research - Melbourne

Recruitment postcode(s) [1]

- Melbourne

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Christchurch

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Zenas BioPharma (USA), LLC

Address

Country

Ethics approval

Ethics application status

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.

Trial website

https://clinicaltrials.gov/study/NCT05638854

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Cory D Sellwood, MBChB

Address

Country

Phone

+6433729477

Fax

[email protected]

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05638854

Trial Review

Registering a new trial?

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