Hepatic AscitesPhase 1NCT05179265
Recombinant Human Serum Albumin in Healthy Subjects
A Phase 1 study testing recombinant human serum albumin and Human serum albumin in people with Hepatic Ascites, run by Beijing Protgen Biotechnology Development Co., Ltd. at 2 sites in China.
Trial summary
This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Ascites
- What is being tested?
- recombinant human serum albumin and Human serum albumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 29 Mar 2021to 7 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, 18 to 55 years old (including the critical value), male or female;
- Body weight ≥45 kg, body mass index (BMI) between 18 and 28 kg/㎡ (including the critical value);
- Throughout the study period (from screening to 3 months after the end of the study), subjects or their spouses voluntarily use effective contraceptive methods, such as abstinence, condoms, intrauterine device (IUD), and double barrier method (such as condoms and diaphragm), and there was no sperm donation plan for men;
- Be willing to participate in clinical trials and sign Informed Consent Form;
- Be able to communicate well with researchers and understand and abide by the requirements of this study.
Who cannot join
- Yeast source antibody positive;
- Investigators consider that there is a clinically significant drug or food allergy, allergic disease history or allergic constitution (≥2 substance allergies), or explicitly allergic to this product or its similar albumin preparation ingredient;
- History of clinical serious disease, including but not limited to circulatory systems, endocrine systems, gastrointestinal tract, kidneys, nervous systems, blood systems, immune systems, mental disease and metabolic abnormalities, and investigators consider that not suitable for clinical trials ;
- History of cardiovascular system disease, including but not limited to vital signs abnormalities (such as systolic pressure <90 mmHg or> 140 mmHg, diastolic pressure <50 mmHg or> 90 mmHg, heart rate <50 bpm or> 100 bpm), severe arrhythmia, Heart failure, unstable angina pectoris, myocardial infarction occurred six months prior to screening ､the tachycardia / translucent that needs drug therapy, three-degree atrioventricular block, QTC interval≥450 ms or electrocardiogram has a clinically significant abnormality;
- Previous has a chronic infectious disease and the investigators can judge possible affecting the evaluation of the drug in trial;
- Surgery of diseases having clinical significance within 4 weeks before administration;
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- Difficulties with blood collection or cannot be resistant to venipuncture , history of needle sickness or blood sickness.
- Alcohol breath test , smoke test or drug urinary screening is positive;
- Physical examination, vital signs, 12 lead electrocardiogram, laboratory examination (blood routine, urine routine, blood biochemical examination, etc.) found that there is a clinical significance;
- One or more positive results for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody;
- A history of drug abuse, or alcohol abuse ( in other words , drinking more than 14 units of alcohol per week [1 unit=360 mL beer or 45 mL of 40% alcoholic spirits or 150 mL wine]) or smoking history (≥5 per day ), or those who cannot smoke during hospitalization;
- Those who use any caffeine-rich food or beverages (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the study drug, or who do not agree to prohibit the use of caffeine-rich food or beverages during the trial;
- Those who have special dietary requirements and cannot follow a unified diet;
- Those who have been treated with corticosteroids or human plasma products within 4 weeks before the trial drug is administered, and have used any prescription drugs, over-the-counter drugs or herbal medicines within 2 weeks (except external preparations or topical preparations);
- Participated in any drug clinical trial within 3 months before administration;
- Those who have donated blood within 4 weeks before dosing or plan to donate blood during the study period or within 4 weeks after the end of the study (>400 mL);
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial;
- Researchers believe that compliance is poor, or those who have other factors that are not suitable for participating in this trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Shenzhen Protgen Co., Ltd.
Shenzhen, Guangdong, 100084
About this study
Official title: A Randomized, Double-blind, Single-dose, Dose-escalated Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Recombinant Human Serum Albumin in Healthy Subjects
This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics.
Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation, and 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo.
Read the detailed description
This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics.
Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation. 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo. Among them, each case in the first dose (2 g) group was enrolled in the group at least 48 hours apart, and was randomly assigned to receive intravenous administration of the test drug or placebo; the first two subjects in the second, third, and fourth dose groups could serve as sentinels. Enrolled at the same time. One patient received the test drug intravenously, the other received a placebo intravenously, and two sentinel subjects completed a single intravenous drug observation for at least 48 hours. If no severe allergic reaction occurred, the group The other subjects in each case were enrolled in the group at least 48 hours apart, and randomly assigned to receive intravenous administration of the test drug or placebo for a single dose of safety, tolerability, pharmacokinetics, and pharmacodynamics And anti-drug antibody test. All subjects should undergo a skin test before receiving the test drug or placebo intravenously, that is, receive an intradermal injection of about 20 mg of the test drug or placebo, and observe the skin test response: if 1 h after the intradermal injection ( ±10 min) If the subject is red, swollen or indurated at the injection site with a diameter of ≤1.5 cm, intravenous administration can be performed, otherwise the subject will have a positive skin test and cannot receive intravenous administration. Subjects who have a positive skin test will withdraw from the test after completing the inspections and operations specified in the protocol. During the test, whether to adjust the positive standard of the skin test reaction will be determined according to the safety information that has been obtained.
- Conditions
- Hepatic Ascites
- Being tested
- recombinant human serum albumin, Human serum albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human serum albuminDrug
10 g/bottle (20%, 50 mL)
Human serum albuminDrug
10 g/bottle (20%, 50 mL)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 0.45 g/bottle，50 mL Receives: Drug: Human serum albumin |
| test group | Experimental | 10 g/bottle (20%, 50 mL) Receives: Drug: recombinant human serum albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAE
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms)., TEAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
Measured: 99 days
SAE
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms). SAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
Measured: 99 days
Secondary outcomes (10)
AUC0-tlast
The PK blood sample collection time point and time window are: within 1 h before intravenous administration, immediately after intravenous administration (+1 min), By collecting within 1 h before intravenous administration, immediately after intravenous administration (+1 min), and after intravenous administration (taking the immediate stop of administration as 0 point) 2 h (± 5 min), 10 h (± 30) min), 24 h (±1 h), 48 h (±1 h), 72 h (±1 h), and D8 (±1 day), D15 (±1 day), D29 (±2 days), D57 (±3 days) blood sample, calculate the PK parameter of the blood sample: AUC0-tlast
Measured: 57 days
Tmax
By collecting within 1 h before intravenous administration, immediately after intravenous administration (+1 min), and after intravenous administration (taking the immediate stop of administration as 0 point) 2 h (± 5 min), 10 h (± 30) min), 24 h (±1 h), 48 h (±1 h), 72 h (±1 h), and D8 (±1 day), D15 (±1 day), D29 (±2 days), D57 (±3 days) blood sample, calculate the PK parameter of the blood sample: Tmax
Measured: 57 days
C0
The PK blood sample collection time point and time window are: within 1 h before intravenous administration, immediately after intravenous administration (+1 min), and after intravenous administration (take the cessation of administration as the 0 point) 2 h (±5) min), 10 h (±30 min), 24 h (±1 h), 48 h (±1 h), 72 h (±1 h), and D8 (±12 h), D15 (±1 day), D29 (± 2 days), D57 (± 3 days), 2 mL of blood was collected respectively.
Measured: 1 day
C8
Collect blood samples on the eighth day（±12 h） and determine the albumin concentration on the eighth day
Measured: 1 day
C15
Collect blood samples on the fifteenth day (±1 day)and determine the albumin concentration on the fifteenth day.
Measured: 1day
C29
Collect blood samples on the 29th day(±2 days) and determine the albumin concentration on the 29th day.
Measured: 1 day
C57
Collect blood samples on the 57th day（±3 days） and determine the albumin concentration on the 57th day.
Measured: 1 day
Cmax
By collecting within 1 h before intravenous administration, immediately after intravenous administration (+1 min), and after intravenous administration (taking the immediate stop of administration as 0 point) 2 h (± 5 min), 10 h (± 30) min), 24 h (±1 h), 48 h (±1 h), 72 h (±1 h), and D8 (±1 day), D15 (±1 day), D29 (±2 days), D57 (±3 days) blood sample, calculate the PK parameter of the blood sample: Cmax
Measured: 57 days
Pharmacodynamic analysis
Plasma colloidal osmotic pressure blood sample collection time point: within 1 hour before intravenous administration, immediately after intravenous administration (+1 min), and after intravenous administration (take the immediate stop of administration as the 0 point) 1 hour (±3 min) ), 3 h (± 5 min), 6 h (± 10 min), 24 h (± 1 h), 48 h (± 1 h), 72 h (± 1 h), about 5 hours of blood will be collected at each time point mL.
Based on the pharmacodynamic analysis set, the statistics of PD indicators of test drugs will be analyzed by descriptive statistical methods.
Measured: 72 h
Evaluate the Anti-Drug antibody (ADA) analysis
The ADA blood sample collection time points are: Day8, Day15, Day29, Day57, and Day99 before the Day1 skin test administration and after the end of the intravenous administration. 6 mL of blood is collected each time, which can be adjusted according to the specific situation. The ADA sample collection time window is the same as the time window of the current visit.
For subjects who have received the trial drug or placebo intravenously and have at least one valid ADA data, the incidence of rHSA ADA and HCP ADA will be summarized respectively. When ADA is positive, further titer and neutralizing antibody (Nab) analysis can be performed.
Measured: 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start29 Mar 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bei Hu, Ph.D, Study director, hubei01_pumch@163.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179265
- Sponsor's protocol ID
- rHSA 2020-1
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2021
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Dose-escalated Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Recombinant Human Serum Albumin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05179265
- Acronym / sponsor ID
- rHSA 2020-1
- Conditions
- Hepatic Ascites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics.
Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation, and 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo.
Detailed description
This trial adopts a single-center, randomized, double-blind, dose-escalation, placebo-controlled design to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single administration of recombinant human serum albumin in healthy subjects Kinetics and anti-drug antibody characteristics.
Qualified healthy subjects (both male and female) were screened and enrolled to the four dose levels of 2 g, 5 g, 10 g, and 20 g according to the principle of dose escalation. 6 out of 8 subjects in each dose group One patient received the test drug, and two received a placebo. Among them, each case in the first dose (2 g) group was enrolled in the group at least 48 hours apart, and was randomly assigned to receive intravenous administration of the test drug or placebo; the first two subjects in the second, third, and fourth dose groups could serve as sentinels. Enrolled at the same time. One patient received the test drug intravenously, the other received a placebo intravenously, and two sentinel subjects completed a single intravenous drug observation for at least 48 hours. If no severe allergic reaction occurred, the group The other subjects in each case were enrolled in the group at least 48 hours apart, and randomly assigned to receive intravenous administration of the test drug or placebo for a single dose of safety, tolerability, pharmacokinetics, and pharmacodynamics And anti-drug antibody test. All subjects should undergo a skin test before receiving the test drug or placebo intravenously, that is, receive an intradermal injection of about 20 mg of the test drug or placebo, and observe the skin test response: if 1 h after the intradermal injection ( ±10 min) If the subject is red, swollen or indurated at the injection site with a diameter of ≤1.5 cm, intravenous administration can be performed, otherwise the subject will have a positive skin test and cannot receive intravenous administration. Subjects who have a positive skin test will withdraw from the test after completing the inspections and operations specified in the protocol. During the test, whether to adjust the positive standard of the skin test reaction will be determined according to the safety information that has been obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Human serum albumin0.45 g/bottle，50 mL |
| test group | Experimental | Drug: recombinant human serum albumin10 g/bottle (20%, 50 mL) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults, 18 to 55 years old (including the critical value), male or female;
- Body weight ≥45 kg, body mass index (BMI) between 18 and 28 kg/㎡ (including the critical value);
- Throughout the study period (from screening to 3 months after the end of the study), subjects or their spouses voluntarily use effective contraceptive methods, such as abstinence, condoms, intrauterine device (IUD), and double barrier method (such as condoms and diaphragm), and there was no sperm donation plan for men;
- Be willing to participate in clinical trials and sign Informed Consent Form;
- Be able to communicate well with researchers and understand and abide by the requirements of this study.
Key exclusion criteria (18 listed)
- Yeast source antibody positive;
- Investigators consider that there is a clinically significant drug or food allergy, allergic disease history or allergic constitution (≥2 substance allergies), or explicitly allergic to this product or its similar albumin preparation ingredient;
- History of clinical serious disease, including but not limited to circulatory systems, endocrine systems, gastrointestinal tract, kidneys, nervous systems, blood systems, immune systems, mental disease and metabolic abnormalities, and investigators consider that not suitable for clinical trials ;
- History of cardiovascular system disease, including but not limited to vital signs abnormalities (such as systolic pressure <90 mmHg or> 140 mmHg, diastolic pressure <50 mmHg or> 90 mmHg, heart rate <50 bpm or> 100 bpm), severe arrhythmia, Heart failure, unstable angina pectoris, myocardial infarction occurred six months prior to screening ､the tachycardia / translucent that needs drug therapy, three-degree atrioventricular block, QTC interval≥450 ms or electrocardiogram has a clinically significant abnormality;
- Previous has a chronic infectious disease and the investigators can judge possible affecting the evaluation of the drug in trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human serum albumin10 g/bottle (20%, 50 mL) | Drug | test group |
| Human serum albumin10 g/bottle (20%, 50 mL) | Drug | Control group |
Primary outcome
TEAE
Time frame: 99 days
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms)., TEAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
SAE
Time frame: 99 days
Adverse events will be coded using MedDRA (International Dictionary of Medical Terms). SAEs related to test drugs were summarized and analyzed according to SOC and PT, and the number of occurrences and the incidence were calculated.
10 secondary outcomes
AUC0-tlast
Time frame: 57 days
Tmax
Time frame: 57 days
C0
Time frame: 1 day
C8
Time frame: 1 day
C15
Time frame: 1day
C29
Time frame: 1 day
C57
Time frame: 1 day
Cmax
Time frame: 57 days
Pharmacodynamic analysis
Time frame: 72 h
Evaluate the Anti-Drug antibody (ADA) analysis
Time frame: 99 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bei Hu, Ph.D study director
hubei01_pumch@163.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant human serum albumin and Human serum albumin in people with Hepatic Ascites, run by Beijing Protgen Biotechnology Development Co., Ltd. at 2 sites 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 5 inclusion and 18 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: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEAE (time frame: 99 days). The study lists 2 primary outcomes in all. 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 11 Mar 2026.