This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
IV infusion
Gold Coast University Hospital ( Site 1601)
Southport, Queensland, Australia
RECRUITINGPart 1: Number of Participants with One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 12 weeks
Part 1: Number of Participants who Discontinue Study Drug Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 4 weeks
Part 2 and Part 3: Number of Participants with One or More AEs
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 52 weeks
Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: Up to approximately 2 weeks
Part 1: Maximum Serum Concentration (Cmax) of MK-1045
Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve.
Time frame: At designated time points up to 12 weeks
Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1045
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Anima Diepenbeek ( Site 0601)
Diepenbeek, Limburg, Belgium
UZ Gent ( Site 0602)
Ghent, Oost-Vlaanderen, Belgium
RECRUITINGChinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)
Beijing, Beijing Municipality, China
RECRUITINGUnion Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)
Wuhan, Hubei, China
RECRUITINGClinica de la Costa S.A.S. ( Site 0101)
Barranquilla, Atlántico, Colombia
RECRUITINGOncomédica S.A.S ( Site 0103)
Montería, Departamento de Córdoba, Colombia
RECRUITINGFundacion Valle del Lili ( Site 0102)
Cali, Valle del Cauca Department, Colombia
RECRUITINGArensia Exploartory Medicine ( Site 1301)
Tbilisi, Georgia
RECRUITINGIstituto Clinico Humanitas- IRCCS ( Site 1902)
Rozzano, Milano, Italy
RECRUITING...and 5 more locations
Blood samples will be collected to determine the AUC0-Inf of MK-1045.
Time frame: At designated time points up to 12 weeks
Part 1: Percentage of Participants with a Peripheral B Cell Count Less Than the Lower Limit of Quantitation (LLOQ) at the End of Each Treatment Period
Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045.
Time frame: At designated time points up to 12 weeks
Part 2 and Part 3: Cmax of MK-1045
Blood samples will be collected to determine the Cmax, obtained directly from the measured value of the plasma concentration-time curve.
Time frame: At designated time points up to 52 weeks
Part 2 and Part 3: Area Under the Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) of MK-1045
Blood samples will be collected to determine the AUCtau of MK-1045.
Time frame: At designated time points up to 52 weeks
Part 2 and Part 3: Percentage of Participants with a Peripheral B Cell Count Less Than the LLOQ at the End of the Treatment Period
Blood samples will be collected to determine the B cell depletion in peripheral blood after treatment with MK-1045.
Time frame: At designated time points up to 52 weeks