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)
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.
⁃ 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.