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
Sponsored by
About this trial
This is an interventional prevention trial for Postmenopausal Osteoporosis focused on measuring osteoporosis,postmenopausal
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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
Email
tjyxboffice@sinq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuhua Ren, Master
Phone
15902713190
Ext
+86
Email
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
Email
tjyxboffice@sinq.com
First Name & Middle Initial & Last Name & Degree
Xiuhua Ren, Master
Phone
15902713190
Ext
+86
Email
271052026@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
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