Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 28, 2025

Primary Completion Date

June 27, 2028

Study Completion Date

June 27, 2028

Conditions
Rheumatoid ArthritisSystemic Lupus Erythematosus
Interventions
BIOLOGICAL

Surovatamig

"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."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY