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Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

NCT04940845 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2021-08-25

No results posted yet for this study

Summary

A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.

Conditions

  • Postmenopausal Osteoporosis

Interventions

DRUG

HS-20090-2

Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day

DRUG

Prolia

Subcutaneously injection of Prolia® (60mg/1mL) once on the first day

Sponsors & Collaborators

  • Shanghai Hansoh Biomedical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Dong Liu, PhD · Huazhong University of Science and Technoogy

  • Xiuhua Ren, Master · Huazhong University of Science and Technoogy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2022-06-30
Completion
2022-06-30

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 NCT04940845 on ClinicalTrials.gov