OsteoporosisPhase 1NCT06753864
A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
A Phase 1 study testing Test (T) and Reference (R) in people with Osteoporosis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence of the two formulations under fasting state. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Test (T) and Reference (R)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2025to 1 May 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Before the test, voluntarily sign informed consent, fully understand the test content, process and possible adverse reactions, and complete the study according to the requirements of the test plan; 2. Female subjects have taken effective contraceptive measures within 14 days before the first dose (self-screening period for male subjects) and are willing to have no pregnancy, sperm donation or egg donation plan from signing informed to 6 months after the last dose, and voluntarily take effective contraceptive measures, specific contraceptive measures are shown in Appendix 2; 3. Male and female subjects aged 40 to 65 years (including boundary values); 4. Male subjects weigh no less than 50.0kg, female subjects weigh no less than 45.0kg, body mass index in the range of 19.0~28.0 kg/m2 (including the critical value).
Who cannot join
- 1. Have a history of serious diseases such as heart, liver, kidney, digestive tract, nervous system, endocrine system, respiratory system and mental disorders, which are considered unsuitable by the study doctor; 2. Clinically significant abnormalities judged by clinicians, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination; 3. Currently suffering from allergic diseases (urticaria, asthma, etc.), or allergies (such as allergies to two or more drugs, foods such as milk or pollen), or known allergies to components or analogues of the drug; 4. Patients with hyperparathyroidism, Paget's disease or history; 5. Past or present postural hypotension or dizziness in the morning; 6. Hyperuricemia (including previous history of gout), hypercalcemia or active urinary calculus; 7. Serum calcium higher than the upper limit of normal, or creatinine clearance <80mL/min(calculation formula: male Ccr(mL/min)= [(140- age)× body weight (kg)]/[0.818× serum creatinine (μmol/L)]; Ccr female =Ccr male ×0.85); 8. Patients who have previously received extra-skeletal beam or implanted radiation therapy; 9. Female subjects who are pregnant, breastfeeding or have positive pregnancy test results; 10. Hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies or syphilis antibodies, any one or more of which are positive 11. Have a history of drug abuse within 5 years, or have used drugs within 3 months before screening, or urine drug screening is positive; 12. Those who consumed an average of more than 14 units of alcohol per week (1 unit =360mL beer or 45mL liquor with 40% alcohol or 150mL wine) in the 3 months prior to screening, or who could not stop alcohol intake from 24h before first dosing to the completion of all blood samples collected, or who tested positive for alcohol breath tests; 13. Those who smoked more than 5 cigarettes per day in the 3 months before screening or stopped using tobacco products during the period of refusal to stay; 14. Had a history of surgery within 3 months prior to screening, or planned to have surgery during the study period; 15. Those who donated blood or lost a lot of blood within 3 months before the first administration (>400mL, except for female physiologic blood loss), or donated platelets ≥2 therapeutic amounts (1 therapeutic amount =12U platelets) within 1 month; 16. Participants in any drug clinical trial and administration within 3 months before the first dose; 17. Those who have received any prescription drugs (including vaccines) within 14 days prior to the first dose; 18. Those who have received any over-the-counter medicines (including birth control pills), Chinese herbs or health products (including vitamins) within 7 days before the first dose; 19. ngested any food rich in xanthines (such as coffee, tea, chocolate, cocoa, milk tea, etc.), grapefruit (grapefruit), pomelo, pomegranate, lime, star fruit and its products, or had intense exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 20. Patients with difficulty in venous blood collection or a history of fainting needles and fainting blood, or skin scars, wounds or tattoos at the injection site, which affect the absorption or observer of injection drugs; 21. Subjects deemed unsuitable for participation by other investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Yu Cao, Doctor, 86-18661809090, caoyu1767@126.com
About this study
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence of the two formulations under fasting state.
- Conditions
- Osteoporosis
- Being tested
- Test (T), Reference (R)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test (T)Drug
Abaloparatide injection, specification :3120 μg/1.56 ml(2000 μg/ml), drug information subject to actual supply, Qilu Pharmaceutical Co., LTD. The test preparations for the subjects are all from the same batch number.
Reference (R)Drug
Abaloparatide injection (Tymlos®), specification :3120 μg/1.56 ml(2000 μg/ml), drug information is subject to actual supply, provided by Qilu Pharmaceutical Co., LTD. The reference preparations for the subjects were all from the same batch number.
| Study group | Role | What they receive |
|---|---|---|
| Test (T)-Reference (R) | Experimental | In this trial, 16 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. Receives: Drug: Test (T); Drug: Reference (R) |
| Reference (R)-Test (T) | Experimental | In this trial, 16 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. Receives: Drug: Test (T); Drug: Reference (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 4 hours
Area under the plasma concentration versus time curve (AUC0-t)
Area under the drug concentration-time curve from time 0 to the 4h accurately measurable concentration at sample collection time
Measured: 4 hours
Area under the plasma concentration versus time curve (AUC0-∞)
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start2 Jan 2025 (estimated)
- Primary completion9 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753864
- Sponsor's protocol ID
- QLCG2128-01
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 31 Dec 2024
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06753864
- Acronym / sponsor ID
- QLCG2128-01
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 9 Jan 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
To investigate the pharmacokinetics of the test preparation abalparatide injection and the reference preparation abalparatide injection (Tymlos®) in healthy adult subjects under fasting state, and to evaluate the bioequivalence of the two formulations under fasting state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (T)-Reference (R) | Experimental | Drug: Test (T), Drug: Reference (R)In this trial, 16 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
| Reference (R)-Test (T) | Experimental | Drug: Test (T), Drug: Reference (R)In this trial, 16 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 2 days. After fasting for at least 10 hours. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Before the test, voluntarily sign informed consent, fully understand the test content, process and possible adverse reactions, and complete the study according to the requirements of the test plan; 2. Female subjects have taken effective contraceptive measures within 14 days before the first dose (self-screening period for male subjects) and are willing to have no pregnancy, sperm donation or egg donation plan from signing informed to 6 months after the last dose, and voluntarily take effective contraceptive measures, specific contraceptive measures are shown in Appendix 2; 3. Male and female subjects aged 40 to 65 years (including boundary values); 4. Male subjects weigh no less than 50.0kg, female subjects weigh no less than 45.0kg, body mass index in the range of 19.0~28.0 kg/m2 (including the critical value).
Key exclusion criteria (1 listed)
- 1. Have a history of serious diseases such as heart, liver, kidney, digestive tract, nervous system, endocrine system, respiratory system and mental disorders, which are considered unsuitable by the study doctor; 2. Clinically significant abnormalities judged by clinicians, including physical examination, vital signs examination, electrocardiogram or clinical laboratory examination; 3. Currently suffering from allergic diseases (urticaria, asthma, etc.), or allergies (such as allergies to two or more drugs, foods such as milk or pollen), or known allergies to components or analogues of the drug; 4. Patients with hyperparathyroidism, Paget's disease or history; 5. Past or present postural hypotension or dizziness in the morning; 6. Hyperuricemia (including previous history of gout), hypercalcemia or active urinary calculus; 7. Serum calcium higher than the upper limit of normal, or creatinine clearance <80mL/min(calculation formula: male Ccr(mL/min)= [(140- age)× body weight (kg)]/[0.818× serum creatinine (μmol/L)]; Ccr female =Ccr male ×0.85); 8. Patients who have previously received extra-skeletal beam or implanted radiation therapy; 9. Female subjects who are pregnant, breastfeeding or have positive pregnancy test results; 10. Hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies or syphilis antibodies, any one or more of which are positive 11. Have a history of drug abuse within 5 years, or have used drugs within 3 months before screening, or urine drug screening is positive; 12. Those who consumed an average of more than 14 units of alcohol per week (1 unit =360mL beer or 45mL liquor with 40% alcohol or 150mL wine) in the 3 months prior to screening, or who could not stop alcohol intake from 24h before first dosing to the completion of all blood samples collected, or who tested positive for alcohol breath tests; 13. Those who smoked more than 5 cigarettes per day in the 3 months before screening or stopped using tobacco products during the period of refusal to stay; 14. Had a history of surgery within 3 months prior to screening, or planned to have surgery during the study period; 15. Those who donated blood or lost a lot of blood within 3 months before the first administration (>400mL, except for female physiologic blood loss), or donated platelets ≥2 therapeutic amounts (1 therapeutic amount =12U platelets) within 1 month; 16. Participants in any drug clinical trial and administration within 3 months before the first dose; 17. Those who have received any prescription drugs (including vaccines) within 14 days prior to the first dose; 18. Those who have received any over-the-counter medicines (including birth control pills), Chinese herbs or health products (including vitamins) within 7 days before the first dose; 19. ngested any food rich in xanthines (such as coffee, tea, chocolate, cocoa, milk tea, etc.), grapefruit (grapefruit), pomelo, pomegranate, lime, star fruit and its products, or had intense exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 20. Patients with difficulty in venous blood collection or a history of fainting needles and fainting blood, or skin scars, wounds or tattoos at the injection site, which affect the absorption or observer of injection drugs; 21. Subjects deemed unsuitable for participation by other investigators.
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 |
|---|---|---|
| Test (T)Abaloparatide injection, specification :3120 μg/1.56 ml(2000 μg/ml), drug information subject to actual supply, Qilu Pharmaceutical Co., LTD. The test preparations for the subjects are all from the same batch number. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
| Reference (R)Abaloparatide injection (Tymlos®), specification :3120 μg/1.56 ml(2000 μg/ml), drug information is subject to actual supply, provided by Qilu Pharmaceutical Co., LTD. The reference preparations for the subjects were all from the same batch number. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 4 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 4 hours
Area under the drug concentration-time curve from time 0 to the 4h accurately measurable concentration at sample collection time
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 4 hours
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- 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.
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 Test (T) and Reference (R) in people with Osteoporosis, run by The Affiliated Hospital of Qingdao University 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 31 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao (86-18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 4 hours). The study lists 3 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 31 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.