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

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07201558

Title field or adapter rule

{'original_value': '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', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:33.961452+00:00

Published At

2026-10-28T00:00:00+00:00

Record Updated At

2026-10-28

Source Retrieved At

2026-10-31T22:18:41.628690+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Rheumatoid Arthritis", "Systemic Lupus Erythematosus"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-28", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07201558"

protocolSection.identificationModule.officialTitle

"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"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE1"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Rheumatoid Arthritis (protocolSection.conditionsModule.conditions)
• Systemic Lupus Erythematosus (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Surovatamig'], 'description': '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:\n\nPart 1 (SAD): Single ascending dose - participants receive one dose of Surovatamig.\n\nPart 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.', 'name': 'Surovatamig', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

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