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A Study to Evaluate the Denosumab in Healthy Adults

NCT03427853 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-02-09

No results posted yet for this study

Summary

This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China

Conditions

  • Healthy Adults

Interventions

DRUG

LY06006

LY06006 18mg, 60mg, 120mg subcutaneous injection

DRUG

Placebos

Placebo subcutaneous injection

Sponsors & Collaborators

  • Shandong Boan Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Huanhuan Jiang · Shangdon Boan Biotechnology Co Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2019-12-28
Completion
2019-12-28

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 NCT03427853 on ClinicalTrials.gov