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

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy People
• Intervention / Treatment: Drug: QL1206; Drug: Xgeva®

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • The first Affiliated Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1206; QL1206 injection (120mg) by subcutaneous injection once on the first day.	Drug: QL1206; subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.
Active Comparator: Xgeva®; Xgeva® injection (120mg) by subcutaneous injection once on the first day.	Drug: Xgeva®; subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.; Other Names: Denosumab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve (AUC0-t )	Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t.	134 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events(AE)	The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.	134 day
serum CTX1	CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.	134 day

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: yanhua DING, Professor, The first Affiliated Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): November 17, 2018
• Study Completion (Actual): May 22, 2019

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab
• Other Study ID Numbers: QL1206-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No