NCT04641364

Safety and Tolerance Study of Recombinant Human Albumin Injection in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A phase I, single-center, randomized, double-blind, placebo-controlled single dose escalation study, and a positive-controlled multiple dose extension study to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy subjects

Detailed description

This study was to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of recombinant human albumin injection in healthy volunteers. The safety, tolerance, pharmacokinetics and immunogenicity of recombinant human albumin injection were evaluated in a single center, randomized, double-blind, placebo-controlled single dose incremental trial in healthy volunteers. The study was divided into two stages: the first stage was a single dose and dose increasing stage (including 5 dose groups with increasing dose, and each group was set with placebo control); the second stage was multiple administration stage (with positive control). The safety, tolerance, pharmacokinetics, immunogenicity and other early clinical data of recombinant human albumin were collected and analyzed in the two stages. The initial dose was 1.25g. The highest dose group was set at 30g. The dose groups of 1.25, 5, 10, 20 and 30 g / time were preset in the single dose stage (dose increasing stage). The dosage was 10 g / Day in multiple administration stage.

Conditions

• Ascites

Interventions

Type	Name	Description
DRUG	recombinant human albumin injection	single dose or multiple doses of intravenous infusion
DRUG	Placebo	Single dose intravenous infusion of 0.9% sodium chloride injection
DRUG	human albumin injection	multiple doses of intravenous infusion

Timeline

• Start date: 2019-06-24
• Primary completion: 2020-05-06
• Completion: 2020-05-06
• First posted: 2020-11-23
• Last updated: 2020-11-23

Locations

1 site across 1 country: China