Recombinant Human Serum Albumin in Healthy Subjects
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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.