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Status unknownNCT04940845Updated Aug 25, 2021

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

A Phase 1 interventional study of HS-20090-2 and Prolia in Postmenopausal Osteoporosis, sponsored by Shanghai Hansoh Biomedical Co., Ltd. Status unknown at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-25.

Sponsored by Shanghai Hansoh Biomedical Co., Ltd · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
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Study 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.

Read the 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.

02

Conditions studied

  • Postmenopausal Osteoporosis

Keywords

  • osteoporosis,postmenopausal
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 174 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Shanghai Hansoh Biomedical Co., Ltd is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
174 participants (estimated)

Study arms

  • Experimental
    HS-20090-2

    Drug: HS-20090-2

  • Active comparator
    Prolia®

    Drug: Prolia

Interventions

  • DrugHS-20090-2

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

  • DrugProlia

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 155days

  2. Cmax

    maximum concentration

    Time frame: 155days

Secondary outcomes

  1. 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.

    Time frame: 155days

  2. ADA

    percentage of subjects positive for antidrug antibody

    Time frame: 155days

  3. Nab

    percentage of subjects positive for Nab

    Time frame: 155days

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Study locations

1 of 1 sites recruiting
  • Huazhong University of Science and Technoogy
    Wuhan, Hubei, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04940845
Lead sponsor
Shanghai Hansoh Biomedical Co., Ltd
Responsible party
Sponsor
First posted
Jun 28, 2021
Start date
Jul 26, 2021
Primary completion
Jun 2022 (estimated)
Completion
Jun 2022 (estimated)
Last update
Aug 25, 2021

Study contacts

Dong Liu, PhD
Contact
tjyxboffice@sinq.com
13507183749 ext. +86
Xiuhua Ren, Master
Contact
271052026@qq.com
15902713190 ext. +86
Dong Liu, PhD
principal investigator · Huazhong University of Science and Technoogy
Xiuhua Ren, Master
principal investigator · Huazhong University of Science and Technoogy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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