A Study to Evaluate LY06006 and Prolia in Healthy Adults

Healthy Adults Clinical Trial

Official title:

A Randomized, Double-blind, Parallel-group Study in Chinese Healthy Male Subjects to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus Prolia Following Single-dose Subcutaneous Injection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04973722
• Other study ID #: LY06006/CT-CHN-103
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 9, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection

Description:

Study Design:

The study is a randomized, double-blind, parallel-group study in healthy adult male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection.

A total of 168 healthy male subjects will be randomized 1:1 to receive a single subcutaneous (s.c.) injection of 60mg of either LY06006 ( LY06006 , 60 mg/1mL , Shandong Luye Pharmaceutical Co., Ltd.) or Prolia (60 mg / 1 mL , Amgen Inc.). During the entire study period, blood samples should be collected according to the Schedule of Assessments for pharmacokinetic, pharmacodynamic and immunogenicity analysis, and safety assessments should be conducted.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: December 31, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Voluntarily signed the informed consent form;

2. Healthy males,ages =18 to =50 years;

3. Body weight =58 to =68 kg and Body mass index (BMI) >18 to <28 kg/m2, body mass index (BMI) = weight ( kg ) / height 2 (m 2);

4. Normal or clinically acceptable vital signs, physical exams, laboratory tests, 12- lead ECG, abdominal color Doppler ultrasound, chest radiograph, etc. screening;

5. No pregnancy plans and voluntarily take effective contraceptive measures from the screening date to the end of the study .

Exclusion Criteria:

1. Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limit to: malignant tumors ( including myeloma ), hypoparathyroidism / hyperthyroidism, hypothyroidism / hyperthyroidism, acromegaly, Cushing ' s syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, rheumatoid arthritis, osteomalacia;

2. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw (ONJ), or risk factors for ONJ such as invasive dental surgery or jaw surgery during the trial, or unhealed dental or oral surgery wounds;

3. Recent bone fracture within 6 months;

4. Active and unhealed infections of the respiratory system, digestive system, urinary system, reproductive system, or skin;

5. Serum calcium of < Lower Limit of Normal (LLN) or > Upper Limit of Normal (ULN);

6. Prior use of medications affecting bone turnover before screening and for the duration of study, including but not limited to: denosumab, bisphosphonates or fluoride within 12 months, contraceptives containing estrogen, tibolone, estrogen, selective estrogen receptor modulators, aromatase inhibitors, calcitonin, strontium salts, parathyroid hormone (or derivatives), vitamin D supplements ( >1000 IU/ day), anabolic steroids, systemic glucocorticoids, calcitriol or similar, diuretics, anticonvulsants within 6 months; inhaled or topical glucocorticoid drugs within 2 weeks;

7. Allergy to more than two drugs or food, or allergy to the ingredients of the investigational medicinal product (IMP);

8. Blood donation or massive blood loss ( =200 mL ) within 3 months before screening ;

9. Any vaccination within 6 months before screening or for the duration of study;

10. Prior use of any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening ;

11. Intense physical exercise within 2 weeks before screening or for the duration of the study, or any other conditions affecting drug absorption, distribution, metabolism, and excretion;

12. Upon enquiry, prior smoke more than 5 cigarettes per day within 3 months before the study;

13. Upon enquiry, a history of alcohol abuse ( drinking more than 14 units of alcohol per week within the first three months prior to screening : 1 unit = 350 mL of beer, 45 mL of liquor, or 150 mL of wine ), or positive alcohol test;

14. Positive urine screen for drug or a history of drug abuse or drug use in the past five years upon questioning ;

15. Other diseases with clinical significance (such as nervous system, mental system , cardiovascular system, urinary system, digestive system, respiratory system, metabolic endocrine system, blood system, skin disease, immune disease, tumor, etc.);

16. Any of the following tests positive: hepatitis B surface antigen ( HBsAg ), hepatitis C antibody ( HCV-AB ), human immunodeficiency virus antigen antibody ( HIVAg / Ab ) and treponema pallidum antibody;

17. Acute diseases or concomitant medications from screening to IMP administration;

18. Consumption of any alcohol-containing products within 48 hours before administration of the IMP ;

19. Prior participation in clinical trials for denosumab or denosumab biosimilar products; current participation in other clinical studies, or receiving or have received any investigational drug within 3 months (or less than 5-half lives of that medication, whichever time period is longer) before receiving study drug ;

20. History of fainting blood or needles;

21. In the opinion of the investigator, others to be excluded.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• LY06006
60 mg/1 ml, once every 6 months administered subcutaneously
• Prolia
60 mg/1 ml, once every 6 months administered subcutaneously

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.	Shan Dong Boan Biotechnology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0- 8	Area under the concentration-time curve from time zero to infinity	168 days
Primary	C max	Maximum observed concentration	168 days
Primary	s-CTX	Percent change in serum s-CTX from baseline.	168 days
Primary	AUEC0-t	The pharmacodynamic parameters	168 days
Primary	Emax	The pharmacodynamic parameters	168 days
Primary	TEmax	The pharmacodynamic parameters	168 days
Secondary	Vital signs:Temperature	Safety measures	168 days
Secondary	Vital signs:pulse	Safety measures	168 days
Secondary	Vital signs: blood pressure	Safety measures	168 days
Secondary	Vital signs: respiration	Safety measures	168 days
Secondary	Physical examination:general	Safety measures	168 days
Secondary	Physical examination:head and neck region	Safety measures	168 days
Secondary	Physical examination:lymph gland	Safety measures	168 days
Secondary	Physical examination: oral cavity	Safety measures	168 days
Secondary	Physical examination:chest	Safety measures	168 days
Secondary	Physical examination:belly	Safety measures	168 days
Secondary	Physical examination:Extremities and spine	Safety measures	168 days
Secondary	Physical examination:nervous system	Safety measures	168 days
Secondary	Laboratory tests:hematology	Safety measures	168 days
Secondary	Laboratory tests:chemistry	Safety measures	168 days
Secondary	Laboratory tests:urinalysis	Safety measures	168 days
Secondary	Laboratory tests:parathyroid hormone	Safety measures	168 days
Secondary	Laboratory tests:thyroid function	Safety measures	168 days
Secondary	Laboratory tests:abdomen ultrasound	Safety measures	168 days
Secondary	Laboratory tests:chest radiography	Safety measures	168 days
Secondary	Laboratory tests:coagulation function	Safety measures	168 days
Secondary	Electrocardiogram (12-Lead ECG)	Safety measures	168 days
Secondary	Adverse events(AEs)	Safety measures	168 days
Secondary	ADA	The incidence and antibody titer of ADA	168 days
Secondary	Nab	The incidence of Nab.	168 days