A Study to Evaluate Safety and Pharmacokinetics of ZB002 in Healthy Participants and Participants With Rheumatoid Arthritis
- Conditions
- Healthy VolunteersRheumatoid Arthritis
- Interventions
- Drug: Placebo
- Registration Number
- NCT05638854
- Lead Sponsor
- Zenas BioPharma (USA), LLC
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: SAD in Healthy Volunteers ZB002 Healthy volunteers will receive a single dose of ZB002 or placebo Part A: SAD in Healthy Volunteers Placebo Healthy volunteers will receive a single dose of ZB002 or placebo Part B: MAD in RA Participants ZB002 RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations Part B: MAD in RA Participants Placebo RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations
- Primary Outcome Measures
Name Time Method Part A: Safety and Tolerability in HVs Day 1 through Day 120 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)
Part B: Safety and Tolerability of multiple doses of ZB002 in participants with RA Day 1 through Day 176 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
- Secondary Outcome Measures
Name Time Method Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC) Day 1 through Day 176 Pharmacokinetics
Part A: Time for Cmax (Tmax) Day 1 through Day 120 Pharmacokinetics
Part A: Terminal half-life (t1/2) Day 1 through Day 120 Pharmacokinetics
Part B: Serum anti-ZB002 antibody prevalence and incidence Day 1 through Day 176 Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) Day 1 through Day 120 Pharmacokinetics
Part A: Maximum observed serum concentration (Cmax) Day 1 through Day 120 Pharmacokinetics
Part A: AUC from time 0 to the last quantifiable concentration (AUClast) Day 1 through Day 120 Pharmacokinetics
Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F) Day 1 through Day 176 Pharmacokinetics
Part A: Apparent clearance following extravascular dosing (CL/F) Day 1 through Day 120 Pharmacokinetics
Part A: Apparent volume of distribution following extravascular administration (Vz/F) Day 1 through Day 120 Pharmacokinetics
Part B (All Doses): Serum trough concentration (Ctrough) Day 1 through Day 176 Before repeat-dose administration (or at the end of the dosing interval \[tau\] after the final dose)
Part B (Doses 1 and 3): Maximum observed serum concentration (Cmax) Day 1 through Day 176 Pharmacokinetics
Part B (Doses 1 and 3): Time for Cmax (Tmax) Day 1 through Day 176 Pharmacokinetics
Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau) Day 1 through Day 176 Pharmacokinetics
Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax) Day 1 through Day 176 Pharmacokinetics
Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) Day 1 through Day 176 Pharmacokinetics
Part B (Dose 3 only): Terminal half-life (t1/2) Day 1 through Day 176 Pharmacokinetics
Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast) Day 1 through Day 176 Pharmacokinetics
Part B: Cytokine/chemokine secretion in ex vivo stimulated whole blood Day 1 through Day 176 Pharmacodynamic
Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F) Day 1 through Day 176 Pharmacokinetics
Trial Locations
- Locations (2)
Veritus Research
🇦🇺Melbourne, Australia
NZCR New Zealand Clinical Research
🇳🇿Christchurch, New Zealand