Recombinant Human Serum Albumin in Healthy Subjects
Condition: Hepatic Ascites
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 1

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.

      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.
    

Intervention name(s): recombinant human serum albumin; Human serum albumin
Intervention type(s): Drug; Drug
Intervention description(s): 10 g/bottle (20%, 50 mL); 10 g/bottle (20%, 50 mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment