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

NCT04641364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-11-23

No results posted yet for this study

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

Conditions

  • Ascites

Interventions

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

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Principal Investigators

  • Junqi Niu, Dr · The first affiliated hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641364 on ClinicalTrials.gov