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

NCT07201558 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

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 & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2028-06-27
Completion
2028-06-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • China
  • Germany
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201558 on ClinicalTrials.gov