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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07201558
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Surovatamig — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Feb 2026
Primary completion
Jun 27, 2028
Completion
Jun 27, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Surovatamig
    Participants will receive Surovatamig subcutaneously in one of three dosing regimens: once (Part 1), twice (Part 2), or three times (Part 3), depending on the study part.

Primary Outcome Measure

Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs) [ Time Frame: Day 1 to end of the study (up to 52 weeks) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteFullertonCalifornia92835-
Research SiteAllenTexas75013-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritisLupus (SLE)
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Research Site· Birmingham, ALResearch Site· Fullerton, CAResearch Site· Allen, TX

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