Share
Save
A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants with Rheumatoid Arthritis
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
PHASE1
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
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part A: SAD in Healthy Volunteers
| DRUG: ZB002
|
EXPERIMENTAL: Part B: MAD in RA Participants
| DRUG: ZB002
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Part A: Maximum observed serum concentration (Cmax) | Pharmacokinetics | Day 1 through Day 120 |
Part A: Time for Cmax (Tmax) | Pharmacokinetics | Day 1 through Day 120 |
Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | Pharmacokinetics | Day 1 through Day 120 |
Part A: AUC from time 0 to the last quantifiable concentration (AUClast) | Pharmacokinetics | Day 1 through Day 120 |
Part A: Terminal half-life (t1/2) | Pharmacokinetics | Day 1 through Day 120 |
Part A: Apparent clearance following extravascular dosing (CL/F) | Pharmacokinetics | Day 1 through Day 120 |
Part A: Apparent volume of distribution following extravascular administration (Vz/F) | Pharmacokinetics | Day 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) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Doses 1 and 3): Time for Cmax (Tmax) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Dose 3 only): Terminal half-life (t1/2) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F) | Pharmacokinetics | Day 1 through Day 176 |
Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F) | Pharmacokinetics | Day 1 through Day 176 |
Part B: Serum anti-ZB002 antibody prevalence and incidence | Not Specified | Day 1 through Day 176 |
Part B: Cytokine/chemokine secretion in ex vivo stimulated whole blood | Pharmacodynamic | Day 1 through Day 176 |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!