A Study to Evaluate LY01011 and Xgeva® in Healthy Adults

NCT ID: NCT04198636

Last Updated: 2019-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2021-06-30

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.

Conditions

Healthy Adults

Keywords

Compare; Pharmacokinetics; Pharmacodynamics; Safety; Immunogenicity; LY01011; Xgeva®; Healthy adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LY01011

LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Group Type: EXPERIMENTAL

LY01011

Intervention Type: DRUG

LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Xgeva®

Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Group Type: ACTIVE_COMPARATOR

Xgeva 120 MG in 1.7 ML Injection

Intervention Type: DRUG

Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Interventions

LY01011

LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

subcutaneous injection of 120 mg (1.7 ml); subcutaneous injection of 120 mg (1.7 ml)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)

UNKNOWN

Sponsor Role: collaborator

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Floor, Building 1, No. 71, Xinmin Street, Changchun, Jilin Province

Central Contacts

Yanhua Ding, MD

Role: CONTACT

Phone: 8618186879768

Email: dingyanhua2003@126.com

Other Identifiers

LY01011/CT-CHN-102

Identifier Type: -

Identifier Source: org_study_id