Healthy AdultsPhase 1NCT03427853
A Study to Evaluate the Denosumab in Healthy Adults
A Phase 1 study testing LY06006 in people with Healthy Adults, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- LY06006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2018to 28 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed ICF and complied with ICF requirement and restrictions
- Healthy male and female, 18≤age≤65
- In screening visit, male body weight≥50kg，female body weight≥45kg，and 19.0≤BMI≤24.0 kg/m2；
- At screening visit: physical examination, vital signs, laboratory tests, electrocardiogram, chest X-ray examination, abdominal CT examination are normal or abnormal but no clinical significance confirmed by investigators；
- During the study period and within 12 months after the study drug administration, the subjects and partners agreed to use reliable contraceptive measures
Who cannot join
- Pregnant or lactating women；
- Fertility plan within one year；
- The subject has a history of hypersensitivity or allergy to LY06006 or any of its excipients；or allergy to any drug, food and pollen, or IGE test is positive.
- 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；
- Active respiratory, digestive, urinary, reproductive or skin infections；
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- Have oncology family history ；
- Have mental illness history；
- In screening visit: Chest X-ray, abdominal CT indicated clinical significance，for example: tuberculosis, inflammation, et al；
- PPD test positive with 48-72 hrs induration reading≥5mm；
- Blood chemistry：ALT or AST >1.5 ULN，Cr>1.0 ULN；Blood routine：WBC<0.8 LLN or>1.2 ULN；NE<0.8 LLN；PLT<0.8 LLN；HGB<0.8LLN；
- Suffering from or have had the following diseases affecting the bone metabolism: malignant tumors (including myeloma), hypoparathyroidism / hyperthyroidism, hypothyroidism, acromegaly, cushing's syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, rheumatoid arthritis, osteomalacia et al;
- The medicines that may affect bone turnover are used before randomization 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，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
- Significant changes in physical activity in 6 months before randomization; or have been playing strenuous sports, or plan to play strenuous sports during the study period.
- Any of HBsAg, HCV-Ab, Anti-HIV, TP-Ab is positive；
- Hypocalcemia or hypercalcemia，or serum calcium calibrated by serum albumin is not within the normal range
- The average daily smoking amount is more than 5 cigarettes per day during three months before randomization, or smoking can't be prohibited during the study period;
- Alcohol abuse or drank more than 28 units / week of alcohol((1 unit =350ml beer, 45ml spirits or 150ml Wine), or alcohol breath test is positive；
- History of drug dependency or drug abuse, or urine drug screening test is positive；
- Donated whole blood, blood component, or massive hemorrhage （>400ml）three months before randomization.
- Use of any vaccines in 6 months of initiation of study therapy
- participation in another clinical trial within 3 months prior to enrollment
- Had Blood faint and acupuncture syncope history；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Xicheng District
Yi Fang, 8610-88326666, fygk7000@163.com
About this study
Official title: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Denosumab Injection Administered Subcutaneously to Healthy Adults in China
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China
Read the detailed description
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study in healthy adults in China, conducted in one center.
The objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection (code name:LY06006).
Subjects would be sequentially enrolled in one of three cohorts. Eight subjects in the first cohort would receive a single 18 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56, the other 16 subjects would be enrolled in the second cohort to receive a single 60 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56 in 60-mg group, the last 8 subjects would be enrolled in the third cohort to receive a single 120 mg subcutaneous injection of LY06006.
- Conditions
- Healthy Adults
- Being tested
- LY06006, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY06006Drug
LY06006 18mg, 60mg, 120mg subcutaneous injection
PlacebosDrug
Placebo subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| LY06006 | Experimental | LY06006 18mg, 60mg 120mg subcutaneous injection Receives: Drug: LY06006 |
| Placebo | Placebo comparator | Placebo subcutaneous injection Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related adverse events
Number of patients with treatment related adverse events assessed by change from baseline
Measured: 56 days
Number of patients with abnormal laboratory values
Number of patients with abnormal laboratory values assessed by change from baseline
Measured: 56 days
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
Measured: 56 days
Area under the Curve (AUC)
Measured: 56 days
Number of patients with anti drug antibodies
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start10 Jan 2018
- Primary completion28 Dec 2019 (estimated)
- Study completion28 Dec 2019 (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
- randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 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
- Huanhuan Jiang, Study director, Shangdon Boan Biotechnology Co Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427853
- Sponsor's protocol ID
- LY06006
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 9 Feb 2018
- 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 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Denosumab Injection Administered Subcutaneously to Healthy Adults in China
- ClinicalTrials.gov ID
- NCT03427853
- Acronym / sponsor ID
- LY06006
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shandong Boan Biotechnology Co., Ltd
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 28 Dec 2019 (estimated)
- Study completion
- 28 Dec 2019 (estimated)
- First posted
- 9 Feb 2018 (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.
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China
Detailed description
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study in healthy adults in China, conducted in one center.
The objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection (code name:LY06006).
Subjects would be sequentially enrolled in one of three cohorts. Eight subjects in the first cohort would receive a single 18 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56, the other 16 subjects would be enrolled in the second cohort to receive a single 60 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56 in 60-mg group, the last 8 subjects would be enrolled in the third cohort to receive a single 120 mg subcutaneous injection of LY06006.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation
| Arm | Type | Receives |
|---|---|---|
| LY06006 | Experimental | Drug: LY06006LY06006 18mg, 60mg 120mg subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo subcutaneous injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed ICF and complied with ICF requirement and restrictions
- Healthy male and female, 18≤age≤65
- In screening visit, male body weight≥50kg，female body weight≥45kg，and 19.0≤BMI≤24.0 kg/m2；
- At screening visit: physical examination, vital signs, laboratory tests, electrocardiogram, chest X-ray examination, abdominal CT examination are normal or abnormal but no clinical significance confirmed by investigators；
- During the study period and within 12 months after the study drug administration, the subjects and partners agreed to use reliable contraceptive measures
Key exclusion criteria (23 listed)
- Pregnant or lactating women；
- Fertility plan within one year；
- The subject has a history of hypersensitivity or allergy to LY06006 or any of its excipients；or allergy to any drug, food and pollen, or IGE test is positive.
- 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；
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 |
|---|---|---|
| LY06006LY06006 18mg, 60mg, 120mg subcutaneous injection | Drug | LY06006 |
| PlacebosPlacebo subcutaneous injection | Drug | Placebo |
Primary outcome
Number of patients with treatment related adverse events
Time frame: 56 days
Number of patients with treatment related adverse events assessed by change from baseline
Number of patients with abnormal laboratory values
Time frame: 56 days
Number of patients with abnormal laboratory values assessed by change from baseline
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 56 days
Area under the Curve (AUC)
Time frame: 56 days
Number of patients with anti drug antibodies
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- 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.
Huanhuan Jiang study director
Shangdon Boan Biotechnology Co Ltd
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 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 23 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 9 Feb 2018. 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. Some participants in this study may receive a placebo. 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 Yi Fang, MD (8610-8832666, fygk7000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment related adverse events (time frame: 56 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 9 Feb 2018.