AzTrials
AzTrials

Hypoalbuminemia in Cirrhotic AscitesPhase 1NCT07851688

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

A Phase 1 study testing Human Serum Albumin(HSA) and GLR1075 Injection in people with Hypoalbuminemia in Cirrhotic Ascites, run by Gan & Lee Pharmaceuticals. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hypoalbuminemia in Cirrhotic Ascites
What is being tested?
Human Serum Albumin(HSA) and GLR1075 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
1 siteChina
Study dates
7 Oct 2026to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • PART A:
  • 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.
  • 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.
Show all 20Show fewer
  • PART B:
  • 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.
  • 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:
  • 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 18-65 years (inclusive).
  • At screening, body mass index (BMI) ≥18.5 and ≤28.0 kg/m².
  • 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.
  • Serum albumin ≤30 g/L at screening.
  • At screening and before randomization/dosing, women of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test.
  • 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.

Who cannot join

  • PATR A:
  • 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.
  • .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.
Show all 42Show fewer
  • Individuals with a history of drug abuse or drug addiction or with a positive drug abuse test within 1 year before screening.
  • 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.
  • 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.
  • 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.
  • 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.
  • Individuals with any food allergy or special dietary requirements who cannot comply with a unified diet or dietary restrictions.
  • Any reason that the investigator considers may prevent the trial participant from participating in the study.
  • PART B:
  • <!-- -->
  • 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.
  • .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.
  • Individuals with a history of drug abuse or drug addiction or with a positive drug abuse test within 1 year before screening.
  • 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.
  • 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.
  • 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.
  • 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.
  • Individuals with any food allergy or special dietary requirements who cannot comply with a unified diet or dietary restrictions.
  • Any reason that the investigator considers may prevent the trial participant from participating in the study.
  • PART C:
  • <!-- -->
  • 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.
  • Individuals who are pregnant or breastfeeding at screening, or who plan to become pregnant during the trial.
  • 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
  • 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).
  • Individuals with severe cardiovascular and cerebrovascular events within 6 months before screening,
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yunda Zhuge contact

zhugeyunda@ganlee.com

China1 site
  • Gan & Lee Pharmaceuticals

    Beijing

    chechen He, 010-56456739, chenchen.he@ganlee.com

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of GLR1075 Injection Following Single and Multiple Dosing in Healthy Trial Participants and Multiple Dosing in Cirrhotic Trial Participants With and Hypoalbuminemia

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.

Being tested
placebo GLR1075 Vehicle, Human Serum Albumin(HSA), GLR1075 Injection
Keywords
GLR1075 Injection;Cirrhotic Ascites; Hypoalbuminemia
Medical subject headings
Hypoalbuminemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebo GLR1075 VehicleDrug

    Single dose of intravenous infusion

  • Human Serum Albumin(HSA)Drug

    human albumin injection multiple doses of intravenous infusion

  • GLR1075 InjectionDrug

    recombinant human albumin injection single dose or multiple doses of intravenous infusion

Study groups in NCT07851688
Study groupRoleWhat they receive
placebo GLR1075 VehiclePlacebo comparatorGLR1075 Vehicle Injection single dose
Receives: Drug: placebo GLR1075 Vehicle
Human Serum Albumin(HSA)Active comparatorGLR1075 Injection multiple doses of intravenous infusion
Receives: Drug: Human Serum Albumin(HSA)
GLR1075 InjectionExperimentalrecombinant human albumin
Receives: Drug: GLR1075 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of AEs, number of AE episodes, and incidence rate of AEs

    Measured: Day1-Day 90 for PART A,Day1-Day 132 for PART B,Day1-Day 104 for PART C

Secondary outcomes (7)
  1. Pharmacokinetics parameters-AUC0-t

    Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)

    Measured: Day 1-Day 90 for Part A,Day 1-Day132 for Part B

  2. Pharmacokinetics parameters-Cmax

    Maximum Plasma Concentration(Cmax)

    Measured: Day 1-Day90 for Part A,Day 1-Day132 for Part B

  3. Pharmacokinetics parameters-Tmax

    time to Maximum Plasma Concentration(Tmax)

    Measured: Day 1-Day 90 for Part A,Day 1-Day132 for Part B

  4. Pharmacodynamic parameters-serum albumin

    Change from baseline in serum albumin level

    Measured: Day 1-Day 90 for Part A, Day 1-Day132 for Part B, Day 1-Day104 for Part C

  5. Pharmacodynamic parameters-Plasma colloid osmotic pressure

    Change from baseline in Plasma colloid osmotic pressure

    Measured: Day 1-Day 30 for Part A,Day 1-Day102 for Part B,Day 1-Day104 for Part C

  6. Efficacy end point-serum albumin level

    The proportion of trial participants whose serum albumin level reached 35g/L during the treatment period

    Measured: Day 1-Day15 for Part C

  7. Immunogenicity-ADA

    Anti-Drug antibody (ADA)

    Measured: Day 1-Day 90 for Part A,Day 1-Day132 for Part B,Day 1-Day104 for Part C

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start7 Oct 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07851688
Sponsor's protocol ID
GLR1075-HCA-101
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Human Serum Albumin(HSA) and GLR1075 Injection in people with Hypoalbuminemia in Cirrhotic Ascites, run by Gan & Lee Pharmaceuticals. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chenchen He (010-56456739, chenchen.he@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of AEs, number of AE episodes, and incidence rate of AEs (time frame: Day1-Day 90 for PART A,Day1-Day 132 for PART B,Day1-Day 104 for PART C). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in