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

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Hansoh Pharma

Status and phase

Unknown
Phase 1

Conditions

Bone Metastasis From Solid Tumors

Treatments

Drug: HS-20090
Drug: Xgeva®

Study type

Interventional

Funder types

Industry

Identifiers

NCT04494373
HS-20090-101

Details and patient eligibility

About

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.

Full description

This is a phase I, single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile,observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.

Enrollment

154 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

154 participants in 2 patient groups

HS-20090
Experimental group
Description:
Subcutaneously injection of HS-20090 (120mg/1.7mL) once on the first day
Treatment:
Drug: HS-20090
Xgeva®
Active Comparator group
Description:
Subcutaneously injection of Xgeva® (120mg/1.7mL) once on the first day
Treatment:
Drug: Xgeva®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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