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

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    174
  • sponsor
    Shanghai Hansoh Biomedical Co., Ltd
Updated on 4 September 2021
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prolia

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.

Details
Condition Osteoporosis, Post-Menopausal Osteopenia, Post-Menopausal Osteoporosis, Postmenopausal osteoporosis
Treatment HS-20090-2, Prolia, Prolia
Clinical Study IdentifierNCT04940845
SponsorShanghai Hansoh Biomedical Co., Ltd
Last Modified on4 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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