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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy People
• Intervention / Treatment: Drug: QL1206; Drug: Prolia®

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 Prolia® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of QL1206 or Prolia® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarities of QL1206 or Prolia® preliminarily. Subjects would receive a single 60mg（1ml） of QL1206 or through subcutaneous injection.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The first Affiliated Hospital of Jilin University
      • Contact: yanhua DING, Professor; Email: dingyanhua2003@126.com
      • Principal Investigator: yanhua Ding, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1206; QL1206 injection (60mg) by subcutaneous injection once on the first day	Drug: QL1206; subcutaneous injection of 60 mg (1ml) only once,on the first day.
Active Comparator: Prolia®; Prolia® injection (120mg) by subcutaneous injection once on the first day	Drug: Prolia®; subcutaneous injection of 60 mg (1ml)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
maximum plasma concentration(Cmax)	the maximum plasma concentration of QL1206/Prolia 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. the secondary outcome measures the percent change in serum CTX1 throughout the study from baseline to 134 day	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): October 31, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 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: QL1206-002

Drug and device information, study documents

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