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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651947
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy People Drug: QL1206 Drug: Xgeva® Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults
Actual Study Start Date : August 20, 2018
Actual Primary Completion Date : November 17, 2018
Actual Study Completion Date : May 22, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arms and Interventions
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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 Name: Denosumab Injection


Outcome Measures
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Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC0-t ) [ Time Frame: 134 day ]
    Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to the last measurable concentration acquisition time t.


Secondary Outcome Measures :
  1. Adverse events(AE) [ Time Frame: 134 day ]
    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.

  2. serum CTX1 [ Time Frame: 134 day ]
    CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651947


Locations
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China, Jilin
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China, 130000
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: yanhua DING, Professor The First Affiliated Hospital of Jilin University
More Information
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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03651947    
Other Study ID Numbers: QL1206-001
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs