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A Study to Evaluate LY01011 and Xgeva® in Healthy Adults

NCT04198636 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-12-13

No results posted yet for this study

Summary

A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults

Conditions

  • Healthy Adults

Interventions

DRUG

LY01011

LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

DRUG

Xgeva 120 MG in 1.7 ML Injection

Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Sponsors & Collaborators

  • Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)

    collaborator UNKNOWN

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, MD · 2nd Floor, Building 1, No. 71, Xinmin Street, Changchun, Jilin Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-12-31
Completion
2021-06-30

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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 NCT04198636 on ClinicalTrials.gov