The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in healthy adult male and female subjects.
In addition, safety, tolerability, PK, and pilot efficacy biomarkers will be evaluated in subjects with cold agglutinin disease (CAD).
Healthy female or male subjects who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Body mass index of 18.0 to 32.0 kg/m², inclusive; and a total body weight > 50 kg up to a maximum of 110 kg.
Study subjects must have received a quadrivalent meningococcal conjugate vaccine (meningococcal serogroups A, C, W, and Y) within the past 5 years or vaccination a minimum of 14 days prior to initial study drug administration.
History of any clinically significant (as determined by the investigator) cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal, or other major disease.
Evidence of clinically significant medical condition or other condition that might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
Signs and symptoms of, or diagnosis consistent with a chronic autoimmune disorder and/or positive antinuclear antibodies (ANA) test by indirect immunofluorescence confirmed by ANA titer ≥ 1:160.
Documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
Sequential
GL-0719
DrugAdministration route: intravenous infusion and subcutaneous injection
Placebo
DrugAdministration route: intravenous infusion and subcutaneous injection
Incidence and severity of adverse events (AEs)
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, physical examination and measurement of cytokines
Area Under the Concentration time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Area Under the Concentration time Curve from Time 0 to the Time of the Last (AUC0-tlast)
Maximum Observed Concentration (Cmax)
Time of the maximum observed concentration (tmax)
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