drugset
drugset / Trial / NCT04641364

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

NCT04641364 ↗

Phase 1 Completed 80 enrolled The First Hospital of Jilin University
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2019-06-24
Primary completion
2020-05-06
Completion
2020-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 10 g Intravenous
Subject Recombinant Human Albumin Protein / enzyme biologic 1.25 g Intravenous
Subject Recombinant Human Albumin Protein / enzyme biologic 5 g Intravenous
Subject Recombinant Human Albumin Protein / enzyme biologic 10 g Intravenous
Subject Recombinant Human Albumin Protein / enzyme biologic 20 g Intravenous
Subject Recombinant Human Albumin Protein / enzyme biologic 30 g Intravenous

Indications

No indication recorded.