Study detail
RecruitingPhase 1
An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus
AstraZeneca
Summary
This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.
Description
This is an open-label, Phase I, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig administered subcutaneously in adult participants aged 18 to 65 years with rheumatoid arthritis or systemic lupus erythematosus. The study includes single-ascending dose cohorts in adult participants with RA (Part 1) and step-up dosing cohorts in adult participants with RA or SLE (Parts 2 and 3).
Eligibility
- Age range
- 18–65 years
- Sex