NCT04940845

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

June 24, 2021

Last Update Submit

August 24, 2021

Conditions

Postmenopausal Osteoporosis

Keywords

osteoporosis，postmenopausal

Outcome Measures

Primary Outcomes (2)

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

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

    155days

  • Cmax

    maximum concentration

    155days

Secondary Outcomes (3)

  • Adverse events(AE)

    155days

  • ADA

    155days

  • Nab

    155days

Study Arms (2)

HS-20090-2

EXPERIMENTAL
Drug: HS-20090-2

Prolia®

ACTIVE COMPARATOR
Drug: Prolia

Interventions

HS-20090-2DRUG

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

HS-20090-2
ProliaDRUG

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

Prolia®

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huazhong University of Science and Technoogy

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Dong Liu, PhD

    Huazhong University of Science and Technoogy

    PRINCIPAL INVESTIGATOR

  • Xiuhua Ren, Master

    Huazhong University of Science and Technoogy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Liu, PhD

CONTACT

13507183749tjyxboffice@sinq.com

Xiuhua Ren, Master

CONTACT

15902713190271052026@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

June 28, 2021

Study Start

July 26, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)