Healthy AdultsPhase 1NCT04198636
A Study to Evaluate LY01011 and Xgeva® in Healthy Adults
A Phase 1 study testing LY01011 and Xgeva 120 MG in 1.7 ML Injection in people with Healthy Adults, run by Luye Pharma Group Ltd..
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- LY01011 and Xgeva 120 MG in 1.7 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2019to 30 Jun 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 ,
- Take any alcoholic product within 48 hours before using the investigational product
- Participation in another clinical trial within 3 months prior to enrollment
- Anticipated of partner pregnancy during the study.
- Other conditions that the investigator thinks unsuitable in this study
Trial locations and contacts
No sites are listed yet.
About this study
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
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
Read the detailed 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.
- Conditions
- Healthy Adults
- Being tested
- LY01011, Xgeva 120 MG in 1.7 ML Injection
- Keywords
- Compare, Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, LY01011, Xgeva®, Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY01011Drug
Also called subcutaneous injection of 120 mg (1.7 ml)
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 InjectionDrug
Also called subcutaneous injection of 120 mg (1.7 ml)
Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
| Study group | Role | What they receive |
|---|---|---|
| LY01011 | Experimental | LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once Receives: 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 Receives: Drug: Xgeva 120 MG in 1.7 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Assess the Cmax similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
Measured: 168 days
AUC0-t
Assess the AUC0-t similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
Measured: 168 days
Secondary outcomes (12)
AE
Number of patients with treatment related adverse events assessed by change from baseline
Measured: 168 days
ADA
Number of patients with ADA
Measured: 168 days
Nab
Number of patients with Nab
Measured: 168 days
AUC0-∞
Assess area under the Curve (AUC)
Measured: 168 days
Tmax
Assess the Tmax
Measured: 168 days
CL/F
Assess the CL/F
Measured: 168 days
λz
Assess the λz
Measured: 168 days
t1/2
Assess the t1/2
Measured: 168 days
Vd/F
Assess the Vd/F
Measured: 168 days
AUEC0-t of CTX-1
Assess the AUEC0-t of CTX-1
Measured: 168 days
Emax
Assess the Emax of CTX-1
Measured: 168 days
TEmax
Assess the TEmax of CTX-1
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 posted13 Dec 2019
- Study start16 Dec 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (estimated)
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
- Yanhua Ding, MD, Principal investigator, 2nd Floor, Building 1, No. 71, Xinmin Street, Changchun, Jilin Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198636
- Sponsor's protocol ID
- LY01011/CT-CHN-102
- Status last verified
- Dec 2019
- First submitted
- 7 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04198636
- Acronym / sponsor ID
- LY01011/CT-CHN-102
- Conditions
- Healthy Adults
- Keywords
- Compare, Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, LY01011, Xgeva®, Healthy adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Study start
- 16 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 13 Dec 2019 (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, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| LY01011 | Experimental | Drug: LY01011LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once |
| Xgeva® | Active comparator | Drug: Xgeva 120 MG in 1.7 ML InjectionXgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| LY01011Also: subcutaneous injection of 120 mg (1.7 ml)LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once | Drug | LY01011 |
| Xgeva 120 MG in 1.7 ML InjectionAlso: subcutaneous injection of 120 mg (1.7 ml)Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once | Drug | Xgeva® |
Primary outcome
Cmax
Time frame: 168 days
Assess the Cmax similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
AUC0-t
Time frame: 168 days
Assess the AUC0-t similarity of single and subcutaneous injections of LY01011 or Xgeva® in healthy volunteers
12 secondary outcomes
AE
Time frame: 168 days
ADA
Time frame: 168 days
Nab
Time frame: 168 days
AUC0-∞
Time frame: 168 days
Tmax
Time frame: 168 days
CL/F
Time frame: 168 days
λz
Time frame: 168 days
t1/2
Time frame: 168 days
Vd/F
Time frame: 168 days
AUEC0-t of CTX-1
Time frame: 168 days
Emax
Time frame: 168 days
TEmax
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 13 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
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.
Yanhua Ding, MD principal investigator
2nd Floor, Building 1, No. 71, Xinmin Street, Changchun, Jilin Province
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY01011 and Xgeva 120 MG in 1.7 ML Injection in people with Healthy Adults, run by Luye Pharma Group Ltd..
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 19 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yanhua Ding, MD (8618186879768, dingyanhua2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 168 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2019.