A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY01011 and Xgeva® in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- LY01011
- Conditions
- Healthy Adults
- Sponsor
- Luye Pharma Group Ltd.
- Enrollment
- 168
- Primary Endpoint
- AUC0-t
- Last Updated
- 6 years ago
Overview
Brief Summary
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
Detailed Description
This is a phase I, randomized, double-blind, single-dose, parallel-group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers. The secondary objective are to compare the safety, tolerability, immunogenicity and pharmacodynamics of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers.
Investigators
Eligibility 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
- •During the study period, the subjects and partners agreed to use reliable contraceptive measures
- •Aged ≥18 years or ≤50 years, male or female (including the boundary value)
- •Male body weight≥50kg，female body weight≥45kg，and 18.0≤BMI≤28.0 kg/m2
- •Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance at screening
Exclusion Criteria
- •Subjects are suffering from or have had osteomyelitis or osteonecrosis of the Jaw, or plan to have invasive dental or maxillofacial surgery during the study, or dental or oral surgery wounds unhealed
- •Have fractures in past six months
- •The medicines that may affect bone turnover are used before screening or planned to use in the study period , including but not limited : Denosumab, bisphosphonates or fluorides were used in past 12 months; Contraceptives with hormone were used in past 6 months，Hormone replacement therapy（tibolone、hormone、selective estrogen receptor modulators）Aromatase inhibitors, calcitonin, strontium salt, parathyroid hormone (or derivative), vitamin D supplement，Anabolic steroids, systemic glucocorticoids, calcitriol or analogues, diuretics, anticonvulsant drugs；Inhalation or local use of glucocorticoids within 2 weeks
- •Hypocalcemia or hypercalcemia，or serum calcium calibrated by serum albumin was not within the normal range
- •Subjects with allergic constitution (allergic to more than two drugs or food) or known to be allergic to the ingredients of the investigational product
- •Donated whole blood, blood component, or massive hemorrhage （\>450ml）three months before screening
- •Use of any vaccines in 4 weeks of initiation of study therapy
- •Use Rx or OTC drugs or nutritional health products or herbal supplements within 14 days before the screening
- •Have been playing strenuous sports in 2 weeks before screening; or other factors affecting drug absorption, distribution, metabolism, excretion
- •The average daily smoking amount is more than 5 cigarettes per day during three months before screening;
Arms & Interventions
LY01011
LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
Intervention: LY01011
Xgeva®
Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
Intervention: Xgeva 120 MG in 1.7 ML Injection
Outcomes
Primary Outcomes
AUC0-t
Time Frame: 168 days
Assess the AUC0-t similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
Cmax
Time Frame: 168 days
Assess the Cmax similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
Secondary Outcomes
- AUEC0-t of CTX-1(168 days)
- Emax(168 days)
- ADA(168 days)
- AE(168 days)
- AUC0-∞(168 days)
- CL/F(168 days)
- t1/2(168 days)
- Vd/F(168 days)
- Tmax(168 days)
- TEmax(168 days)
- Nab(168 days)
- λz(168 days)