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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940845
• Other study ID #: HS-20090-2-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 26, 2021
• Est. completion date: June 2022

Study information

• Verified date: August 2021
• Source: Hansoh BioMedical R&D Company
• Contact: Dong Liu, PhD
• Phone: 13507183749
• Email: tjyxboffice[@]sinq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. 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;

2. Healthy males, Aged =18 years or =50 years old(including the boundary value);

3. Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered;

4. 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:

1. 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;

2. Serum calcium levels are outside the normal range of the laboratory.

3. 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.

4. 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).

5. 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• HS-20090-2
Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day
• Prolia
Subcutaneously injection of Prolia® (60mg/1mL) once on the first day

Locations

Country	Name	City	State
China	Huazhong University of Science and Technoogy	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hansoh Biomedical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-infinity curve (AUC0-8 )	Area under the plasma concentration-time curve (AUC0-t ) from 0 o'clock to infinite time.	155days
Primary	Cmax	maximum concentration	155days
Secondary	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.	155days
Secondary	ADA	percentage of subjects positive for antidrug antibody	155days
Secondary	Nab	percentage of subjects positive for Nab	155days