Overview
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2021-06-30
2021-06-30
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Criteria
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