Back to results

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Primary Purpose

Postmenopausal Osteoporosis

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HS-20090-2

Prolia

About this trial

This is an interventional prevention trial for Postmenopausal Osteoporosis focused on measuring osteoporosis，postmenopausal

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 12 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

Huazhong University of Science and TechnoogyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HS-20090-2

Prolia®

Arm Description

Outcomes

Primary Outcome Measures

Area under the plasma concentration-infinity curve (AUC0-∞ )

Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.

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.

ADA

percentage of subjects positive for antidrug antibody

Nab

percentage of subjects positive for Nab

Full Information

NCT ID

NCT04940845

First Posted

June 24, 2021

Last Updated

August 24, 2021

Sponsor

Shanghai Hansoh Biomedical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04940845

Brief Title

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Official Title

A Randomized, Single-blinded and Parallel Study to Assess the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 26, 2021 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Hansoh Biomedical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A randomized, single-blind and parallel group study to compare the pharmacokinetic, safety and immunogenicity of HS-20090-2 60mg#1ml#and Prolia® in healthy adults.

Detailed Description

This is a phase I, single center, randomized, single-blind and parallel group clinical trial .The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090-2 or Prolia® in healthy volunteers.

6. Conditions and Keywords

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

Postmenopausal Osteoporosis

Keywords

osteoporosis，postmenopausal

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HS-20090-2

Arm Type

Experimental

Arm Title

Prolia®

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

HS-20090-2

Intervention Description

Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day

Intervention Type

Drug

Intervention Name(s)

Prolia

Intervention Description

Subcutaneously injection of Prolia® (60mg/1mL) once on the first day

Primary Outcome Measure Information:

Title

Area under the plasma concentration-infinity curve (AUC0-∞ )

Description

Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.

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

ADA

Description

percentage of subjects positive for antidrug antibody

Time Frame

155days

Title

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 12 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Liu, PhD

Phone

13507183749

Ext

+86

tjyxboffice@sinq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiuhua Ren, Master

Phone

15902713190

Ext

+86

271052026@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Liu, PhD

Organizational Affiliation

Huazhong University of Science and Technoogy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiuhua Ren, Master

Organizational Affiliation

Huazhong University of Science and Technoogy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huazhong University of Science and Technoogy

City

Wuhan

State/Province

Hubei

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dong liu, PhD

Phone

13507183749

Ext

+86

tjyxboffice@sinq.com

First Name & Middle Initial & Last Name & Degree

Xiuhua Ren, Master

Phone

15902713190

Ext

+86

271052026@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults

We'll reach out to this number within 24 hrs