Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults

NCT ID: NCT03651947

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2019-05-22

Brief Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of QL1206 and Xgeva® in healthy adults.

Detailed Description

This is a phase I,single center, randomized, double-blind and parallel group clinical trial .

The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.

The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.

Meanwhile，observing the pharmacodynamic similarities of QL1206 or Xgeva® preliminarily.

Subjects would receive a single 120mg（1.7ml） of QL1206 or through subcutaneous injection.

Conditions

Healthy People

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

QL1206

QL1206 injection (120mg) by subcutaneous injection once on the first day.

Group Type: EXPERIMENTAL

QL1206

Intervention Type: DRUG

subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

Xgeva®

Xgeva® injection (120mg) by subcutaneous injection once on the first day.

Group Type: ACTIVE_COMPARATOR

Xgeva®

Intervention Type: DRUG

subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

Interventions

QL1206

subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

Intervention Type: DRUG

Xgeva®

subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.

Intervention Type: DRUG

Other Intervention Names

Denosumab Injection

Eligibility Criteria

Inclusion Criteria

• Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
• Aged ≥18 years or ≤50 years, male or female (including the boundary value);
• Agree to take effective contraceptive measures throughout the study period (including not limited to: hormonal drugs of pregnancy, physical contraception, surgery, abstinence, etc., until at least 6 months after the last study is administered;
• Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.

Exclusion Criteria

• Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
• Serum calcium levels are outside the normal range of the laboratory, or the subject uses calcium supplements in the screening period.
• The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
• Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yanhua DING, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Jilin University

Locations

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

QL1206-001

Identifier Type: -

Identifier Source: org_study_id