A Study to Evaluate LY06006 and Prolia in Healthy Adults

NCT04973722 | Unknown Phase 1

• 1 other identifier: LY06006/CT-CHN-103
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Adults

Keywords

Compare; Pharmacokinetics; Pharmacodynamics; Safety; Immunogenicity; LY06006; Prolia; Healthy Adults

Outcome Measures

Primary Outcomes (6)

• AUC 0- ∞

  Area under the concentration-time curve from time zero to infinity

  168 days

• C max

  Maximum observed concentration

  168 days

• s-CTX

  Percent change in serum s-CTX from baseline.

  168 days

• AUEC0-t

  The pharmacodynamic parameters

  168 days

• Emax

  The pharmacodynamic parameters

  168 days

• TEmax

  The pharmacodynamic parameters

  168 days

Secondary Outcomes (24)

• Vital signs：Temperature

  168 days

• Vital signs：pulse

  168 days

• Vital signs： blood pressure

  168 days

• Vital signs： respiration

  168 days

• Physical examination：general

  168 days

Study Arms (2)

LY06006

EXPERIMENTAL

60 mg/1 ml, once every 6 months administered subcutaneously

Drug: LY06006

Prolia

ACTIVE COMPARATOR

60 mg/1 ml, once every 6 months administered subcutaneously

Drug: Prolia

Interventions

LY06006 DRUG

60 mg/1 ml, once every 6 months administered subcutaneously

Also known as: subcutaneous injection of 60 mg

LY06006

Prolia DRUG

60 mg/1 ml, once every 6 months administered subcutaneously

Also known as: Denosumab

Prolia

Eligibility Criteria

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

You may qualify if:

• Voluntarily signed the informed consent form;
• Healthy males，ages ≥18 to ≤50 years;
• 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);
• Normal or clinically acceptable vital signs, physical exams, laboratory tests, 12- lead ECG, abdominal color Doppler ultrasound, chest radiograph, etc. screening;
• No pregnancy plans and voluntarily take effective contraceptive measures from the screening date to the end of the study .

You may not qualify if:

• 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;
• 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;
• Recent bone fracture within 6 months;
• Active and unhealed infections of the respiratory system, digestive system, urinary system, reproductive system, or skin;
• Serum calcium of \< Lower Limit of Normal (LLN) or \> Upper Limit of Normal (ULN);
• 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;
• Allergy to more than two drugs or food, or allergy to the ingredients of the investigational medicinal product (IMP);
• Blood donation or massive blood loss ( ≥200 mL ) within 3 months before screening ;
• Any vaccination within 6 months before screening or for the duration of study;
• Prior use of any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines within 14 days before screening ;
• 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;
• Upon enquiry, prior smoke more than 5 cigarettes per day within 3 months before the study;
• 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;
• Positive urine screen for drug or a history of drug abuse or drug use in the past five years upon questioning ;
• 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.);

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead
• Shan Dong Boan Biotechnology Co., Ltd: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• Wang S, Yang X, Huang J, Yang S, Wu Q, Chen H, Wu S, Dou C, Yang G, Xiang Y. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects. Expert Opin Investig Drugs. 2022 Oct;31(10):1133-1142. doi: 10.1080/13543784.2022.2120389. Epub 2022 Sep 7.

  PMID: 36045484 DERIVED

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Guoping Yang, doctor

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: July 22, 2021
• Study Start: December 9, 2020
• Primary Completion: April 10, 2021
• Study Completion: December 31, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)