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Study on Single Administration and Dose Increment of Recombinant Human Serum Albumin/Erythrocyte Fusion Protein for Injection

NCT03786289 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-10-08

No results posted yet for this study

Summary

The purpose of the study was to evaluate the safety of rHSA/EPO to healthy subjects and to investigate the pharmacokinetic characteristics of rHSA/EPO in healthy subjects, and to obtain preliminary pharmacokinetic parameters.

Conditions

  • Healthy Subjects

Interventions

BIOLOGICAL

Recombinant human serum albumin/erythropoietin fusion protein

Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1

BIOLOGICAL

Recombinant erythropoietin injection (CHO cells)

Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1

Sponsors & Collaborators

  • Tianjin SinoBiotech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-07-03
Completion
2019-12-09

Countries

  • China

Study Locations

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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 NCT03786289 on ClinicalTrials.gov