A Phase 1 interventional study of recombinant human serum albumin and Human serum albumin in Hepatic Ascites, sponsored by Protgen Ltd. Completed at 2 sites in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Protgen Ltd · Phase 1, Interventional, and Treatment
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.
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.
Protgen Ltd is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.45 g/bottle，50 mL
Drug: Human serum albumin
10 g/bottle (20%, 50 mL)
Drug: recombinant human serum albumin
10 g/bottle (20%, 50 mL)
10 g/bottle (20%, 50 mL)
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.
Time frame: 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.
Time frame: 99 days
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
Time frame: 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
Time frame: 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.
Time frame: 1 day
C8
Collect blood samples on the eighth day（±12 h） and determine the albumin concentration on the eighth day
Time frame: 1 day
C15
Collect blood samples on the fifteenth day (±1 day)and determine the albumin concentration on the fifteenth day.
Time frame: 1day
C29
Collect blood samples on the 29th day(±2 days) and determine the albumin concentration on the 29th day.
Time frame: 1 day
C57
Collect blood samples on the 57th day（±3 days） and determine the albumin concentration on the 57th day.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 99 days
Plan to share: No
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