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Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults

NCT04798313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-03-15

No results posted yet for this study

Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

MW031

Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.

DRUG

Prolia®

Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.

Sponsors & Collaborators

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-02
Primary Completion
2020-12-07
Completion
2020-12-31

Countries

  • China

Study Locations

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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 NCT04798313 on ClinicalTrials.gov