Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

NCT04494373 | Unknown Phase 1

• 1 other identifier: HS-20090-101
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.

Conditions

Bone Metastasis From Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve (AUC0-t )

  155days

• Cmax

  maximum concentration

  155days

Secondary Outcomes (2)

• Adverse events(AE)

  155days

• Serum type 1 C-telopeptide(CTX1)

  155days

Other Outcomes (2)

• Antidrug antibody(ADA):

  155days

• Neutralizing antibody(Nab)

  155days

Study Arms (2)

HS-20090

EXPERIMENTAL

Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day

Drug: HS-20090

Xgeva®

ACTIVE COMPARATOR

Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day

Drug: Xgeva®

Interventions

HS-20090 DRUG

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

HS-20090

Xgeva® DRUG

A human IgG2 monoclonal antibody with affinity and specificity for human RANKL

Xgeva®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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 6 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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Related Publications (1)

• Lin Y, Yang H, Yang X, Guo C, Yang S, Yang G, Wu Q, Pan C, Sun C, Li C, He L, Huang J, Pei Q. Biosimilarity of HS-20090 to Denosumab in healthy Chinese subjects: a randomized, double-blinded, pharmacokinetics/pharmacodynamics study. Expert Opin Investig Drugs. 2022 Oct;31(10):1125-1132. doi: 10.1080/13543784.2022.2123737. Epub 2022 Sep 16.

  PMID: 36112084 DERIVED

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 31, 2020
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 4, 2020

Record last verified: 2020-07