AstraZeneca
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.
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).
Inclusion Criteria: 1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent. 2. For RA participants, only: <!-- --> 1. Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria 2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. (a) RF (b) ACPA 3. Moderate or severe disease activity defined as: DAS28-CRP \> 3.2 AND * 4 tender joints and ≥ 4 swollen joints (a) US-Specific Criterion: DAS28-CRP \> 3.2 AND ≥…
Surovatamig is a bispecific T-cell engager administered subcutaneously. This is an open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Surovatamig in adult participants with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). The study consists of up to three parts: Part 1 (SAD): Single ascending dose - participants receive one dose of Surovatamig. Part 2 (sSUD): Single step-up dosing - participants receive two doses. Part 3 (dSUD): Double step-up dosing - participants receive three doses. Participants are assigned to a study part based on protocol-defined criteria. The study includes follow-up for a minimum of 179 days post-first dose, with extended monitoring up to 12 months for certain participants.