Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Phase 1
48
about 2.6 years
18–65
3 sites in AL, CA, TX
What this study is about
Researchers are testing the safety and tolerability of surovatamig in adults with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). The trial will also look at how the medication affects the body's processes after it is given as a subcutaneous injection.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Surovatamig
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), Safety of surovatamig: Incidence of AEs/SAEs leading to discontinuation of surovatamig, Tolerability of surovatamig: Incidence of treatment-related clinical laboratory abnormalities, Tolerability of surovatamig: Incidence of treatment-related vital signs abnormalities, Tolerability of surovatamig: Number of participants with abnormal ECG
Secondary: Serum Pharmacokinetics (PK) parameters of surovatamig - AUC0-last, Serum Pharmacokinetics (PK) parameters of surovatamig - AUCinf, Serum Pharmacokinetics (PK) parameters of surovatamig - AUCtau, Serum Pharmacokinetics (PK) parameters of surovatamig - Cmax
Immune