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Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Primary Purpose

Bone Metastasis From Solid Tumors

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

HS-20090

Xgeva®

About this trial

This is an interventional prevention trial for Bone Metastasis From Solid Tumors

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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;
Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);
Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug 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; 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;
Serum calcium levels are outside the normal range of the laboratory.
Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer).
Prior use of medications within 6 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HS-20090

Xgeva®

Arm Description

Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day

Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time curve (AUC0-t )

Cmax

maximum concentration

Secondary Outcome Measures

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.

Serum type 1 C-telopeptide(CTX1)

explore the pharmacodynamic profile by detecting the serum concentration of CTX1

Full Information

NCT ID

NCT04494373

First Posted

July 28, 2020

Last Updated

July 31, 2020

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04494373

Brief Title

Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Official Title

A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）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 subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Metastasis From Solid Tumors

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HS-20090

Arm Type

Experimental

Arm Description

Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day

Arm Title

Xgeva®

Arm Type

Active Comparator

Arm Description

Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day

Intervention Type

Drug

Intervention Name(s)

HS-20090

Intervention Description

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

Intervention Type

Drug

Intervention Name(s)

Xgeva®

Intervention Description

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

Primary Outcome Measure Information:

Title

Area under the plasma concentration-time curve (AUC0-t )

Time Frame

155days

Title

Cmax

Description

maximum concentration

Time Frame

155days

Secondary Outcome Measure Information:

Title

Adverse events(AE)

Description

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.

Time Frame

155days

Title

Serum type 1 C-telopeptide(CTX1)

Description

explore the pharmacodynamic profile by detecting the serum concentration of CTX1

Time Frame

155days

Other Pre-specified Outcome Measures:

Title

Antidrug antibody(ADA):

Description

percentage of subjects positive for antidrug antibody

Time Frame

155days

Title

Neutralizing antibody(Nab)

Description

percentage of subjects positive for Nab

Time Frame

155days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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; Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value); Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug 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; 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; Serum calcium levels are outside the normal range of the laboratory. Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer). Prior use of medications within 6 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics

12. IPD Sharing Statement

Citations:

PubMed Identifier

36112084

Citation

Lin Y, Yang H, Yang X, Guo C, Yang S, Yang G, Wu Q, Pan C, Sun C, Li C, He L, Huang J, Pei Q. Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opin Investig Drugs. 2022 Oct;31(10):1125-1132. doi: 10.1080/13543784.2022.2123737. Epub 2022 Sep 16.

Results Reference

derived

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Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

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