A Study to Evaluate LY01011 and Xgeva® in Healthy Adults

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04198636
• Other study ID #: LY01011/CT-CHN-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 16, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2019
• Source: Luye Pharma Group Ltd.
• Contact: Yanhua Ding, MD
• Phone: 8618186879768
• Email: dingyanhua2003[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.	Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Assess the Cmax similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers	168 days
Primary	AUC0-t	Assess the AUC0-t similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers	168 days
Secondary	AE	Number of patients with treatment related adverse events assessed by change from baseline	168 days
Secondary	ADA	Number of patients with ADA	168 days
Secondary	Nab	Number of patients with Nab	168 days
Secondary	AUC0-8	Assess area under the Curve (AUC)	168 days
Secondary	Tmax	Assess the Tmax	168 days
Secondary	CL/F	Assess the CL/F	168 days
Secondary	?z	Assess the ?z	168 days
Secondary	t1/2	Assess the t1/2	168 days
Secondary	Vd/F	Assess the Vd/F	168 days
Secondary	AUEC0-t of CTX-1	Assess the AUEC0-t of CTX-1	168 days
Secondary	Emax	Assess the Emax of CTX-1	168 days
Secondary	TEmax	Assess the TEmax of CTX-1	168 days