A Study to Evaluate LY01011 and Xgeva® in Healthy Adults

NCT04198636 | Unknown Phase 1

• 1 other identifier: LY01011/CT-CHN-102
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Adults

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• AE

  168 days

• ADA

  168 days

• Nab

  168 days

• AUC0-∞

  168 days

• Tmax

  168 days

Study Arms (2)

LY01011

EXPERIMENTAL

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

Drug: LY01011

Xgeva®

ACTIVE COMPARATOR

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

Interventions

LY01011 DRUG

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

Also known as: subcutaneous injection of 120 mg (1.7 ml)

LY01011

Xgeva 120 MG in 1.7 ML Injection DRUG

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

Also known as: subcutaneous injection of 120 mg (1.7 ml)

Xgeva®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• History of drug abuse or alcohol abuse (drank more than 14 units / week of alcohol: 1 unit =285ml beer, 25ml spirits or 100ml Wine)；
• History of drug abuse within 5 years prior to screening, or urine drug screening test was positive；
• 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.)
• Any of HBsAg, HCV-Ab, Anti-HIV, TP-Ab was positive
• Acute disease or combination of medication from the screening to the study before the use of investigational product ,

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shang Dong Boan Biotechnology Co., Ltd (Co-sponsor): collaborator

MeSH Terms

Interventions

Denosumab; Injections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yanhua Ding, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanhua Ding, MD

CONTACT

8618186879768; dingyanhua2003@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: December 13, 2019
• Study Start: December 16, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share