NCT03427853

A Study to Evaluate the Denosumab in Healthy Adults

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study in healthy adults in China, conducted in one center. The objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection (code name:LY06006). Subjects would be sequentially enrolled in one of three cohorts. Eight subjects in the first cohort would receive a single 18 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56, the other 16 subjects would be enrolled in the second cohort to receive a single 60 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56 in 60-mg group, the last 8 subjects would be enrolled in the third cohort to receive a single 120 mg subcutaneous injection of LY06006.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	LY06006	LY06006 18mg, 60mg, 120mg subcutaneous injection
DRUG	Placebos	Placebo subcutaneous injection

Timeline

• Start date: 2018-01-10
• Primary completion: 2019-12-28
• Completion: 2019-12-28
• First posted: 2018-02-09
• Last updated: 2018-02-09

Locations

1 site across 1 country: China