A Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of GLR1075 Injection in Healthy Trial Participants and Cirrhotic Trial Participants With Ascites and Hypoalbuminemia

• PART A:

  1. 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.
  2. At the time of informed consent, Male or female aged 18-55 years (inclusive)..
  3. 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.
  4. At screening and before randomization and dosing, women of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test.
  5. From the time of signing the informed consent form until 90 days after administration of the investigational medicinal product, female trial participants of childbearing potential、male trial participants and their partners must agree to use reliable contraceptive measures, and trial participants must not donate eggs (oocytes, ova) or sperm for assisted reproductive purposes.

PART B：

1. 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.
2. At the time of informed consent, Male or female aged 18-55 years (inclusive)..
3. 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.
4. At screening and before randomization and dosing, women of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test.
5. From the time of signing the informed consent form until 90 days after administration of the investigational medicinal product, female trial participants of childbearing potential、male trial participants and their partners must agree to use reliable contraceptive measures, and trial participants must not donate eggs (oocytes, ova) or sperm for assisted reproductive purposes.

PART C:

1. 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.
2. At the time of informed consent, Male or female aged 18-65 years (inclusive).
3. At screening, body mass index (BMI) ≥18.5 and ≤28.0 kg/m².
4. Diagnosed with cirrhotic ascites based on clinical, laboratory, or imaging findings in accordance with the 《Guidelines for the Diagnosis and Treatment of Cirrhotic Ascites (2023)》 issued by the Chinese Society of Hepatology, and abdominal ultrasound at screening confirms grade 1-2 ascites.
5. Serum albumin ≤30 g/L at screening.
6. At screening and before randomization/dosing, women of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test.
7. From the time of signing the informed consent form until 90 days after the last administration of the investigational medicinal product, female trial participants of childbearing potential and male trial participants and their partners must agree to use reliable contraceptive measures (see Appendix 1), and trial participants must not donate eggs (oocytes, ova) or sperm for assisted reproductive purposes.

Exclusion Criteria:

• PATR A:

  1. 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.
  2. Individuals who are pregnant or breastfeeding at screening, or who plan to become pregnant during the trial.
  3. 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 ;
  4. 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.
  5. .Individuals who have participated in another interventional clinical trial and received intervention within 3 months before screening (calculated from the last visit of the above clinical trial) or within 5 half-lives of other investigational medicinal products (whichever is longer); or who plan to participate in another clinical trial before completing all scheduled assessments in this trial.
  6. Individuals with a history of drug abuse or drug addiction or with a positive drug abuse test within 1 year before screening.
  7. Individuals who consume more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 mL beer, or 45 mL spirits, or 150 mL wine, or who cannot abstain from alcohol during the trial, or with a positive alcohol breath test at screening.
  8. Individuals who smoke more than 5 cigarettes per day within 3 months before screening, or who cannot stop using any tobacco products during the trial, or who consume tobacco products within 48 hours before randomization and dosing.
  9. Individuals who consume excessive tea, coffee, and/or caffeine-rich beverages (more than 8 cups per day, 1 cup ≈ 250 mL) daily within 3 months before screening.
  10. Individuals with a history of needle or blood phobia, or who cannot or are unwilling to undergo repeated venipuncture due to poor tolerance or difficult venous access.
  11. Individuals with any food allergy or special dietary requirements who cannot comply with a unified diet or dietary restrictions.

  12. Any reason that the investigator considers may prevent the trial participant from participating in the study.

      PART B：

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  1. 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.
  2. Individuals who are pregnant or breastfeeding at screening, or who plan to become pregnant during the trial.
  3. 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 ;
  4. 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.
  5. .Individuals who have participated in another interventional clinical trial and received intervention within 3 months before screening (calculated from the last visit of the above clinical trial) or within 5 half-lives of other investigational medicinal products (whichever is longer); or who plan to participate in another clinical trial before completing all scheduled assessments in this trial.
  6. Individuals with a history of drug abuse or drug addiction or with a positive drug abuse test within 1 year before screening.
  7. Individuals who consume more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 mL beer, or 45 mL spirits, or 150 mL wine, or who cannot abstain from alcohol during the trial, or with a positive alcohol breath test at screening.
  8. Individuals who smoke more than 5 cigarettes per day within 3 months before screening, or who cannot stop using any tobacco products during the trial, or who consume tobacco products within 48 hours before randomization and dosing.
  9. Individuals who consume excessive tea, coffee, and/or caffeine-rich beverages (more than 8 cups per day, 1 cup ≈ 250 mL) daily within 3 months before screening.
  10. Individuals with a history of needle or blood phobia, or who cannot or are unwilling to undergo repeated venipuncture due to poor tolerance or difficult venous access.
  11. Individuals with any food allergy or special dietary requirements who cannot comply with a unified diet or dietary restrictions.

  12. Any reason that the investigator considers may prevent the trial participant from participating in the study.

      PART C:

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  1. 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, or food allergy.
  2. Individuals who are pregnant or breastfeeding at screening, or who plan to become pregnant during the trial.
  3. Individuals with severe digestive system diseases and complications that the investigator considers unsuitable for participation in this study, including but not limited to Child-Pugh grade C at screening or before randomization, grade 3 or 4 hepatic encephalopathy
  4. Individuals with a history of malignant tumors within 5 years before screening (except for adequately treated or resected non-metastatic basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix).
  5. Individuals with severe cardiovascular and cerebrovascular events within 6 months before screening,
  6. Individuals with poorly controlled blood pressure at screening, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg without medication or after stable medication.
  7. Individuals with any of the following abnormal laboratory and/or imaging findings at screening or before randomization:

  1) Complete blood count: absolute neutrophil count \<1.0×10⁹/L, platelets \<30×10⁹/L, white blood cells \<2.0×10⁹/L, hemoglobin \<75 g/L; 2) Blood chemistry: ALT and/or AST >5.0× ULN, total bilirubin >3.0× ULN; eGFR \<60 mL/min/1.73 m²; 3) Coagulation function: international normalized ratio (INR) >1.5; 4) Urinalysis: urine protein ≥1+ and the investigator determines that the participant is unsuitable for the trial; 8. Individuals with a history of drug abuse or drug addiction within 1 year before screening, or with positive alcohol breath test or drug abuse test at screening.

  9. Individuals who consume more than 14 units of alcohol per week within 3 months before screening: 1 unit ≈ 360 mL beer, or 45 mL spirits, or 150 mL wine, or who cannot abstain from alcohol during the trial, or with a positive alcohol breath test at screening.

  10. Individuals who smoke more than 5 cigarettes per day within 3 months before screening, or who cannot stop using any tobacco products during the trial.

  11 Individuals who have participated in another interventional clinical trial and received intervention within 3 months before screening (calculated from the last visit of the above clinical trial) or within 5 half-lives of other investigational medicinal products (whichever is longer); or who plan to participate in another clinical trial before completing all scheduled assessments in this trial.

  12. Individuals with a history of needle or blood phobia, or who cannot or are unwilling to undergo repeated venipuncture due to poor tolerance or difficult venous access.

  13. Any reason that the investigator considers may prevent the trial participant from participating in the study.