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

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