What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Surovatamig. The registry lists allocation as randomized. This open-label, Phase I study will assess the whether it is safe and how hard side effects are to live with of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.
They plan to enroll about 48 people at 34 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
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
Interventions: Surovatamig
Primary outcome (registry wording): Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs)