A Study to Evaluate LY01011 and Xgeva® in Healthy Adults

A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY01011 and Xgeva® in Healthy Adults

A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults

Study Overview

• Status: Unknown
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: LY01011; Drug: Xgeva 120 MG in 1.7 ML Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. During the study period, the subjects and partners agreed to use reliable contraceptive measures
3. Aged ≥18 years or ≤50 years, male or female (including the boundary value)
4. Male body weight≥50kg，female body weight≥45kg，and 18.0≤BMI≤28.0 kg/m2
5. 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:

1. 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
2. Have fractures in past six months
3. 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
4. Hypocalcemia or hypercalcemia，or serum calcium calibrated by serum albumin was not within the normal range
5. Subjects with allergic constitution (allergic to more than two drugs or food) or known to be allergic to the ingredients of the investigational product
6. Donated whole blood, blood component, or massive hemorrhage （>450ml）three months before screening
7. Use of any vaccines in 4 weeks of initiation of study therapy
8. Use Rx or OTC drugs or nutritional health products or herbal supplements within 14 days before the screening
9. Have been playing strenuous sports in 2 weeks before screening; or other factors affecting drug absorption, distribution, metabolism, excretion
10. The average daily smoking amount is more than 5 cigarettes per day during three months before screening;
11. History of drug abuse or alcohol abuse (drank more than 14 units / week of alcohol: 1 unit =285ml beer, 25ml spirits or 100ml Wine)；
12. History of drug abuse within 5 years prior to screening, or urine drug screening test was positive；
13. other clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, metabolic endocrine system, blood system, skin diseases, immune diseases, tumors, etc.)
14. Any of HBsAg, HCV-Ab, Anti-HIV, TP-Ab was positive
15. Acute disease or combination of medication from the screening to the study before the use of investigational product ,
16. Take any alcoholic product within 48 hours before using the investigational product
17. Participation in another clinical trial within 3 months prior to enrollment
18. Anticipated of partner pregnancy during the study.
19. Other conditions that the investigator thinks unsuitable in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY01011; LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once	Drug: LY01011; LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once; Other Names: subcutaneous injection of 120 mg (1.7 ml)
Active Comparator: Xgeva®; Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once	Drug: Xgeva 120 MG in 1.7 ML Injection; Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once; Other Names: subcutaneous injection of 120 mg (1.7 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Assess the Cmax similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers	168 days
AUC0-t	Assess the AUC0-t similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers	168 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	Number of patients with treatment related adverse events assessed by change from baseline	168 days
ADA	Number of patients with ADA	168 days
Nab	Number of patients with Nab	168 days
AUC0-∞	Assess area under the Curve (AUC)	168 days
Tmax	Assess the Tmax	168 days
CL/F	Assess the CL/F	168 days
λz	Assess the λz	168 days
t1/2	Assess the t1/2	168 days
Vd/F	Assess the Vd/F	168 days
AUEC0-t of CTX-1	Assess the AUEC0-t of CTX-1	168 days
Emax	Assess the Emax of CTX-1	168 days
TEmax	Assess the TEmax of CTX-1	168 days

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.
• Collaborators: Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)
• Investigators: Principal Investigator: Yanhua Ding, MD, 2nd Floor, Building 1, No. 71, Xinmin Street, Changchun, Jilin Province

Study record dates

Study Major Dates

• Study Start (Anticipated): December 16, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: December 7, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Immunogenicity; Pharmacodynamics; Healthy adults; Compare; LY01011; Xgeva®
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab
• Other Study ID Numbers: LY01011/CT-CHN-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No