This trial is conducted in China. This study plans to include 3 parts,Part A, a single ascending dose (SAD) study in healthy trial participants; Part B, a multiple dose (MD) study in healthy trial participants; and Part C, a multiple ascending dose (MAD) study in cirrhotic trial participants with ascites and hypoproteinemia. All parts are intended to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of GLR1075.
Signed informed consent form (ICF) prior to the trial, with a full understanding of the trial content, procedures, and possible adverse reactions, and able to comply with the contraindications and restrictions specified in this protocol.
At the time of informed consent, Male or female aged 18-55 years (inclusive)..
At screening, body mass index (BMI) ≥18.5 and ≤26.0 kg/m², with body weight ≥50.0 kg for males and ≥45.0 kg for females.
At screening and before randomization and dosing, women of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test.
Individuals with an allergic constitution, or a history of allergic diseases such as bronchial asthma, urticaria, or eczema, or known allergy, hypersensitivity, or intolerance to the investigational medicinal product or similar products or their excipients, any human plasma-derived human albumin component.
Individuals who are pregnant or breastfeeding at screening, or who plan to become pregnant during the trial.
At screening or before randomization，individuals with clinically significant abnormalities, as judged by the investigator, in physical examination, vital signs, laboratory tests (complete blood count, urinalysis, blood chemistry, coagulation function), posteroanterior chest X-ray or chest CT, abdominal and urinary system ultrasound, 12-lead electrocardiogram, or other auxiliary examinations ;
Individuals with diseases of the nervous system, endocrine system, cardiovascular system, respiratory system, hematologic system, immune system, psychiatric system, digestive system, abnormal liver function, abnormal renal function (eGFR <90 mL/min/1.73 m²), musculoskeletal system, or any other disease or physiological condition that could significantly alter the absorption, metabolism, or elimination of the drug, as well as individuals with suspected and/or confirmed history of tumors at screening or before randomization.
Parallel
placebo GLR1075 Vehicle
DrugSingle dose of intravenous infusion
Human Serum Albumin(HSA)
Drughuman albumin injection multiple doses of intravenous infusion
GLR1075 Injection
Drugrecombinant human albumin injection single dose or multiple doses of intravenous infusion
Number of AEs, number of AE episodes, and incidence rate of AEs
Pharmacokinetics parameters-AUC0-t
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration （AUC0-t）
Pharmacokinetics parameters-Cmax
Maximum Plasma Concentration(Cmax)
Pharmacokinetics parameters-Tmax
time to Maximum Plasma Concentration（Tmax）
Pharmacodynamic parameters-serum albumin
Change from baseline in serum albumin level
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This trial is not recruiting at the moment. You can still explore other options:
