Bone Metastasis From Solid Tumors Clinical Trial
Official title:
A Randomized, Double-blinded and Parallel Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults
| Verified date | July 2020 |
| Source | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 154 |
| Est. completion date | June 30, 2021 |
| Est. primary completion date | June 30, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Antidrug antibody(ADA): | percentage of subjects positive for antidrug antibody | 155days | |
| Other | Neutralizing antibody(Nab) | percentage of subjects positive for Nab | 155days | |
| Primary | Area under the plasma concentration-time curve (AUC0-t ) | 155days | ||
| Primary | Cmax | maximum concentration | 155days | |
| Secondary | Adverse events(AE) | The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment. | 155days | |
| Secondary | Serum type 1 C-telopeptide(CTX1) | explore the pharmacodynamic profile by detecting the serum concentration of CTX1 | 155days |