NCT07201558

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 and step-up dosing cohorts.

Conditions

• Rheumatoid Arthritis
• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-02
• Primary completion: 2028-06-27
• Completion: 2028-06-27
• First posted: 2025-10-01
• Last updated: 2026-02-17

Locations

19 sites across 9 countries: United States, Australia, Belgium, Brazil, China, Germany, Spain, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study