MedTrace Logo

Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

NCT05777109 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-08-23

No results posted yet for this study

Summary

A Dual-center , Randomized, double-blinded and Parallel-controlled Study to Assess the Pharmacokinetic, pharmacodynamics, Safety and Immunogenicity of HS-20090 Injection and Xgeva® in Healthy Adults

Conditions

  • Healthy

Interventions

DRUG

HS-20090

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

DRUG

Xgeva®

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

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoai He, Master · Haikou People's Hospital

  • Wei Zhao, Ph.D · Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-04-20
Primary Completion
2024-04-05
Completion
2024-04-05

Countries

  • China

Study Locations

More Related Trials

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 NCT05777109 on ClinicalTrials.gov