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.
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/m² 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.
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.
Sequential
ZB002
DrugZB002 will be administered subcutaneously as per schedule specified in the respective arm.
Placebo
DrugPlacebo will be administered subcutaneously as per schedule specified in the respective arm.
ZB002
DrugZB002 will be administered subcutaneously as per schedule specified in the respective arm.
Placebo
DrugPlacebo will be administered subcutaneously as per schedule specified in the respective arm.
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)
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
Part A: Maximum observed serum concentration (Cmax)
Pharmacokinetics
Part A: Time for Cmax (Tmax)
Pharmacokinetics
Part A: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Pharmacokinetics
Part A: AUC from time 0 to the last quantifiable concentration (AUClast)
Pharmacokinetics
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