Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subje… (NCT05318534) | Clinical Trial Compass
RecruitingPhase 1
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
United Kingdom70 participantsStarted 2022-04-08
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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/m\^2, 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.
✓. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
✓. Female or male subjects who, at the time of screening, are at least 18 years of age with a total body weight of ≥ 50 kg.
✓. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
✓. The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence and severity of adverse events (AEs)
Timeframe: Day 1 to Follow-up (Day 31±2)
2
Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
Timeframe: Screening (Days -42 to -15) to Follow-up (Day 31±2)
3
Incidence of abnormal clinical laboratory findings in 12-lead ECG parameters, vital signs, physical examination and measurement of cytokines
Timeframe: Screening (Days -42 to -15) to Follow-up (Day 31±2)
. 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.
✕. Any underlying medical condition that, in the opinion of the investigator, renders the subject a poor candidate for this study or could confound the results of the study or put the subject at undue risk.
✕. CAD secondary to infection or an autoimmune disorder.
✕. CAD secondary to active lymphoid or other hematologic malignancy not meeting the inclusion criteria.
✕. Diagnosis of any other malignancy except for adequately treated basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the subject has been disease-free for ≥ 5 years.