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)
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Zenas BioPharma (USA), LLC
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Part A: Safety and Tolerability in HVs
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A: SAD in Healthy Volunteers
Healthy volunteers will receive a single dose of ZB002 or placebo
Intervention: Placebo
Part A: SAD in Healthy Volunteers
Healthy volunteers will receive a single dose of ZB002 or placebo
Intervention: ZB002
Part B: MAD in RA Participants
RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations
Intervention: ZB002
Part B: MAD in RA Participants
RA participants will receive ZB002 or placebo every 4 weeks (Q4W) × 3 administrations
Intervention: Placebo
Outcomes
Primary Outcomes
Part A: Safety and Tolerability in HVs
Time Frame: 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
Time Frame: 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 Outcomes
- Part A: Time for Cmax (Tmax)(Day 1 through Day 120)
- Part A: Terminal half-life (t1/2)(Day 1 through Day 120)
- 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)
- Part A: Maximum observed serum concentration (Cmax)(Day 1 through Day 120)
- Part A: AUC from time 0 to the last quantifiable concentration (AUClast)(Day 1 through Day 120)
- Part B (Dose 3 only): Apparent clearance following extravascular dosing (CL/F)(Day 1 through Day 176)
- Part A: Apparent clearance following extravascular dosing (CL/F)(Day 1 through Day 120)
- Part B (Doses 1 and 3): Accumulation ratio of AUC (ARAUC)(Day 1 through Day 176)
- Part B (All Doses): Serum trough concentration (Ctrough)(Day 1 through Day 176)
- Part B (Doses 1 and 3): Maximum observed serum concentration (Cmax)(Day 1 through Day 176)
- Part A: Apparent volume of distribution following extravascular administration (Vz/F)(Day 1 through Day 120)
- Part B (Doses 1 and 3): Time for Cmax (Tmax)(Day 1 through Day 176)
- Part B (Doses 1 and 3): AUC over the dosing interval, tau (AUCtau)(Day 1 through Day 176)
- Part B (Doses 1 and 3): Accumulation ratio of Cmax (ARCmax)(Day 1 through Day 176)
- Part B (Dose 3 only): Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)(Day 1 through Day 176)
- Part B (Dose 3 only): Terminal half-life (t1/2)(Day 1 through Day 176)
- Part B (Dose 3 only): AUC from time 0 to the last quantifiable concentration (AUClast)(Day 1 through Day 176)
- Part B: Cytokine/chemokine secretion in ex vivo stimulated whole blood(Day 1 through Day 176)
- Part B (Dose 3 only): Apparent volume of distribution following extravascular (Vz/F)(Day 1 through Day 176)