Healthy AdultsPhase 1NCT04973722
A Study to Evaluate LY06006 and Prolia in Healthy Adults
A Phase 1 study testing LY06006 and Prolia in people with Healthy Adults, run by Luye Pharma Group Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- LY06006 and Prolia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2020to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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;
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- 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.);
- 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;
- Acute diseases or concomitant medications from screening to IMP administration;
- Consumption of any alcohol-containing products within 48 hours before administration of the IMP ;
- 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 ;
- History of fainting blood or needles;
- In the opinion of the investigator, others to be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
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
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
Read the detailed 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.
- Conditions
- Healthy Adults
- Being tested
- LY06006, Prolia
- Keywords
- Compare, Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, LY06006, Prolia, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY06006Drug
Also called subcutaneous injection of 60 mg
60 mg/1 ml, once every 6 months administered subcutaneously
ProliaDrug
Also called Denosumab
60 mg/1 ml, once every 6 months administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| LY06006 | Experimental | 60 mg/1 ml, once every 6 months administered subcutaneously Receives: Drug: LY06006 |
| Prolia | Active comparator | 60 mg/1 ml, once every 6 months administered subcutaneously Receives: Drug: Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0- ∞
Area under the concentration-time curve from time zero to infinity
Measured: 168 days
C max
Maximum observed concentration
Measured: 168 days
s-CTX
Percent change in serum s-CTX from baseline.
Measured: 168 days
AUEC0-t
The pharmacodynamic parameters
Measured: 168 days
Emax
The pharmacodynamic parameters
Measured: 168 days
TEmax
The pharmacodynamic parameters
Measured: 168 days
Secondary outcomes (24)
Vital signs：Temperature
Safety measures
Measured: 168 days
Vital signs：pulse
Safety measures
Measured: 168 days
Vital signs： blood pressure
Safety measures
Measured: 168 days
Vital signs： respiration
Safety measures
Measured: 168 days
Physical examination：general
Safety measures
Measured: 168 days
Physical examination：head and neck region
Safety measures
Measured: 168 days
Physical examination：lymph gland
Safety measures
Measured: 168 days
Physical examination： oral cavity
Safety measures
Measured: 168 days
Physical examination：chest
Safety measures
Measured: 168 days
Physical examination：belly
Safety measures
Measured: 168 days
Physical examination：Extremities and spine
Safety measures
Measured: 168 days
Physical examination：nervous system
Safety measures
Measured: 168 days
Laboratory tests：hematology
Safety measures
Measured: 168 days
Laboratory tests：chemistry
Safety measures
Measured: 168 days
Laboratory tests：urinalysis
Safety measures
Measured: 168 days
Laboratory tests：parathyroid hormone
Safety measures
Measured: 168 days
Laboratory tests：thyroid function
Safety measures
Measured: 168 days
Laboratory tests：abdomen ultrasound
Safety measures
Measured: 168 days
Laboratory tests：chest radiography
Safety measures
Measured: 168 days
Laboratory tests：coagulation function
Safety measures
Measured: 168 days
Electrocardiogram (12-Lead ECG)
Safety measures
Measured: 168 days
Adverse events(AEs)
Safety measures
Measured: 168 days
ADA
The incidence and antibody titer of ADA
Measured: 168 days
Nab
The incidence of Nab.
Measured: 168 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start9 Dec 2020
- Primary completion10 Apr 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Guoping Yang, doctor, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973722
- Sponsor's protocol ID
- LY06006/CT-CHN-103
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36045484
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04973722
- Acronym / sponsor ID
- LY06006/CT-CHN-103
- Conditions
- Healthy Adults
- Keywords
- Compare, Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, LY06006, Prolia, Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY06006 | Experimental | Drug: LY0600660 mg/1 ml, once every 6 months administered subcutaneously |
| Prolia | Active comparator | Drug: Prolia60 mg/1 ml, once every 6 months administered subcutaneously |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (21 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY06006Also: subcutaneous injection of 60 mg60 mg/1 ml, once every 6 months administered subcutaneously | Drug | LY06006 |
| ProliaAlso: Denosumab60 mg/1 ml, once every 6 months administered subcutaneously | Drug | Prolia |
Primary outcome
AUC 0- ∞
Time frame: 168 days
Area under the concentration-time curve from time zero to infinity
C max
Time frame: 168 days
Maximum observed concentration
s-CTX
Time frame: 168 days
Percent change in serum s-CTX from baseline.
AUEC0-t
Time frame: 168 days
The pharmacodynamic parameters
Emax
Time frame: 168 days
The pharmacodynamic parameters
TEmax
Time frame: 168 days
The pharmacodynamic parameters
24 secondary outcomes
Vital signs：Temperature
Time frame: 168 days
Vital signs：pulse
Time frame: 168 days
Vital signs： blood pressure
Time frame: 168 days
Vital signs： respiration
Time frame: 168 days
Physical examination：general
Time frame: 168 days
Physical examination：head and neck region
Time frame: 168 days
Physical examination：lymph gland
Time frame: 168 days
Physical examination： oral cavity
Time frame: 168 days
Physical examination：chest
Time frame: 168 days
Physical examination：belly
Time frame: 168 days
Physical examination：Extremities and spine
Time frame: 168 days
Physical examination：nervous system
Time frame: 168 days
Laboratory tests：hematology
Time frame: 168 days
Laboratory tests：chemistry
Time frame: 168 days
Laboratory tests：urinalysis
Time frame: 168 days
Laboratory tests：parathyroid hormone
Time frame: 168 days
Laboratory tests：thyroid function
Time frame: 168 days
Laboratory tests：abdomen ultrasound
Time frame: 168 days
Laboratory tests：chest radiography
Time frame: 168 days
Laboratory tests：coagulation function
Time frame: 168 days
Electrocardiogram (12-Lead ECG)
Time frame: 168 days
Adverse events(AEs)
Time frame: 168 days
ADA
Time frame: 168 days
Nab
Time frame: 168 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 36045484Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoping Yang, doctor principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY06006 and Prolia in people with Healthy Adults, run by Luye Pharma Group Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0- ∞ (time frame: 168 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04973722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.