Postmenopausal OsteoporosisPhase 1NCT04747392
Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults
A Phase 1 study testing SAL001 and FORSTEO in people with Postmenopausal Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study. 64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- SAL001 and FORSTEO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2020to 11 Nov 2020
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who volunteer to participate in the trial and sign the informed consent form.
- Healthy Chinese male or female adults, the number of single sex volunteers is no less than 1/3, aged 20 to 50 years old (including the boundary value).
- Males weighted ≥50kg, females weighted ≥45kg, body mass index (BMI) between 19-25 kg/m^2 (including boundary value), BMI= weight (kg)/height^2 (m^2).
Who cannot join
- The existence of clinically significant diseases of heart, liver, lung, kidney, digestive tract, endocrine, metabolic and hematological systems.
- history of parathyroid disease, or abnormal PTH with clinically significance judged by investigators.
- Physical examination, laboratory examination, electrocardiogram (ECG), chest radiograph, abdominal ultrasound san(digestive system, urinary system), vital signs, etc., indicate that the subject has clinically significant abnormalities judged by the investigator.
- Serum total calcium > upper limit of normal according to the normal range of the center, or previous hypercalcemia.
- Hyperuricemia, or a previous history of gout, or abnormal blood uric acid with clinically significance judged by investigators at the time of screening.
- Those with active urolithiasis.
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- Those who had received anti-osteoporosis agents (such as bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulator, parathyroid hormone and its analogues, strontium salts, active vitamin D and its analogues, vitamin K2, etc.) within 6 months before the first administration of the trial.
- Those who had received oral or intravenous administration of glucocorticoids 3 months before the first administration of the trial.
- Those who had taken any drug within 14 days before the first administration of the trial.
- Allergies, such as allergic to two or more kinds of drugs or food; or known allergic to this drug components.
- Alcoholism within 1 year before screening (drinking more than 3 times a day or more than 7 times a week, drinking 1 time =150mL red wine, or 360mL beer, or 50mL white wine), or a positive alcohol breath test.
- A history of drug abuse within 1 year before screening, or a positive urine test for drugs at screening.
- Those who were smoking more than 5 cigarettes a day within 3 months before screening.
- Those who had participated in any other clinical trial within 3 months before the first administration of the trial.
- Those who had blood donation or blood loss ≥400mL within 3 months before the first administration of the trial.
- Those who do not agree to avoid the use of tobacco, alcohol or caffeinated beverages within 24 hours before the administration and during the trial, or do not agree to avoid strenuous exercise, or do not agree to avoid other factors affecting the absorption, distribution, metabolism and excretion of the drug.
- Women who are pregnant or lactating, or who are positive for serum HCG, or who cannot/do not follow the instructions of investigators to take contraceptive measures approved by investigators during the study period.
- Those who intend to give birth within 1 year.
- Those with positive results of HBV surface antigen, or hepatitis C virus antibody positive, or Treponema pallidum antibody positive, or human immunodeficiency virus antibody positive.
- Those with positive results of novel coronavirus nucleic acid test.
- Those who are considered to be unsuitable for participation in this clinical study by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: A Randomized, Open, Self-crossover, Single-dose Clinical Study to Compare Pharmacokinetic of Teriparatide Injection (SAL001) and the Original Drug FORSTEO in Healthy Chinese Adult Volunteers
This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study.
64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period.
If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- SAL001, FORSTEO
- Keywords
- Teriparatide; Bioequivalence
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL001Biological
administrated once by subcutaneous injection
FORSTEOBiological
administrated once by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Other | The test drug (SAL001) is administrated once by subcutaneous injection in the first period, and the reference drug (FORSTEO) is administrated once by subcutaneous injection in the second period. Receives: Biological: SAL001; Biological: FORSTEO |
| Sequence B | Other | The reference drug (FORSTEO) is administrated once by subcutaneous injection in the first period, and the test drug (SAL001) is administrated once by subcutaneous injection in the second period. Receives: Biological: SAL001; Biological: FORSTEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters: area under the plasma concentration time curve from-time zero to time t (AUC0-t)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: peak plasma concentration (Cmax)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
Secondary outcomes (14)
PK parameters: area under the plasma concentration time curve from time zero to time infinity (AUC0-∞)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: time to reach peak drug concentration (Tmax)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: half-life (t1/2)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: AUC extrapolated from Tmax to infinity in percentage of the total AUC (AUC%extrap)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: time to last measurable concentration (Tlast)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: terminal elimination rate constant (λz)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: apparent total clearance (CL/F)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: apparent distribution volume (Vz/F)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: mean residence time from time zero to t (MRT0-t)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: mean residence time from time zero to infinity (MRT0-∞)
Central lab will be used to detect the plasma concentration of drugs.
Measured: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PD parameters: area under the serum concentration time curve from-time zero to time t (AUC0-t)
Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters.
Measured: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
PD parameters: area under the serum concentration time curve from time zero to time infinity (AUC0-∞)
Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters.
Measured: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
PD parameters: peak serum concentration (Cmax)
Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters.
Measured: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
PD parameters: time to reach peak serum concentration (Tmax)
Central lab will be used to detect the serum total calcium concentration. Serum-corrected calcium concentration will be use to calculate above PD parameters.
Measured: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start19 Aug 2020
- Primary completion30 Oct 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747392
- Sponsor's protocol ID
- SAL001A101
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 10 Feb 2021
- 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 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Self-crossover, Single-dose Clinical Study to Compare Pharmacokinetic of Teriparatide Injection (SAL001) and the Original Drug FORSTEO in Healthy Chinese Adult Volunteers
- ClinicalTrials.gov ID
- NCT04747392
- Acronym / sponsor ID
- SAL001A101
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Teriparatide; Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 10 Feb 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.
This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study.
64 qualified subjects will be randomly assigned to two administration sequences (sequence A and sequence B) at the ratio of 1∶1, with 32 subjects in each sequence. Each period will be given subcutaneous injection once, and the washout period will be 72 hours, and each subject will be given subcutaneous injection twice. Sequence A: the test drug (SAL001) is injected in the first period, and the reference drug (FORSTEO) is injected in the second period. Sequence B: the reference drug (FORSTEO) is injected in the first period, and the test drug (SAL001) is injected in the second period.
If the geometric mean ratio (GMR) 90% confidence interval of the major pharmacokinetic indexes (AUC0-t, Cmax) for SAL001 and FORSTEO is between 80.00% and 125.00%, the two drugs are considered to be bioequivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Other | Biological: SAL001, Biological: FORSTEOThe test drug (SAL001) is administrated once by subcutaneous injection in the first period, and the reference drug (FORSTEO) is administrated once by subcutaneous injection in the second period. |
| Sequence B | Other | Biological: SAL001, Biological: FORSTEOThe reference drug (FORSTEO) is administrated once by subcutaneous injection in the first period, and the test drug (SAL001) is administrated once by subcutaneous injection in the second period. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Those who volunteer to participate in the trial and sign the informed consent form.
- Healthy Chinese male or female adults, the number of single sex volunteers is no less than 1/3, aged 20 to 50 years old (including the boundary value).
- Males weighted ≥50kg, females weighted ≥45kg, body mass index (BMI) between 19-25 kg/m^2 (including boundary value), BMI= weight (kg)/height^2 (m^2).
Key exclusion criteria (21 listed)
- The existence of clinically significant diseases of heart, liver, lung, kidney, digestive tract, endocrine, metabolic and hematological systems.
- history of parathyroid disease, or abnormal PTH with clinically significance judged by investigators.
- Physical examination, laboratory examination, electrocardiogram (ECG), chest radiograph, abdominal ultrasound san(digestive system, urinary system), vital signs, etc., indicate that the subject has clinically significant abnormalities judged by the investigator.
- Serum total calcium > upper limit of normal according to the normal range of the center, or previous hypercalcemia.
- Hyperuricemia, or a previous history of gout, or abnormal blood uric acid with clinically significance judged by investigators at the time of screening.
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 |
|---|---|---|
| SAL001administrated once by subcutaneous injection | Biological | Sequence A, Sequence B |
| FORSTEOadministrated once by subcutaneous injection | Biological | Sequence A, Sequence B |
Primary outcome
PK parameters: area under the plasma concentration time curve from-time zero to time t (AUC0-t)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
Central lab will be used to detect the plasma concentration of drugs.
PK parameters: peak plasma concentration (Cmax)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
Central lab will be used to detect the plasma concentration of drugs.
14 secondary outcomes
PK parameters: area under the plasma concentration time curve from time zero to time infinity (AUC0-∞)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: time to reach peak drug concentration (Tmax)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: half-life (t1/2)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: AUC extrapolated from Tmax to infinity in percentage of the total AUC (AUC%extrap)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: time to last measurable concentration (Tlast)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: terminal elimination rate constant (λz)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: apparent total clearance (CL/F)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: apparent distribution volume (Vz/F)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: mean residence time from time zero to t (MRT0-t)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PK parameters: mean residence time from time zero to infinity (MRT0-∞)
Time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4
PD parameters: area under the serum concentration time curve from-time zero to time t (AUC0-t)
Time frame: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
PD parameters: area under the serum concentration time curve from time zero to time infinity (AUC0-∞)
Time frame: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
PD parameters: peak serum concentration (Cmax)
Time frame: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
PD parameters: time to reach peak serum concentration (Tmax)
Time frame: Within 60 minutes before administration, and 120, 180, 240, 360, 480, 720 minutes after administration of Day 1 and Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SAL001 and FORSTEO in people with Postmenopausal Osteoporosis, run by Shenzhen Salubris Pharmaceuticals Co., 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 3 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: finished, as of the sponsor's last update on 10 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PK parameters: area under the plasma concentration time curve from-time zero to time t (AUC0-t) (time frame: Within 60 minutes before administration, and 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 210, 240, and 300 minutes after administration of Day 1 and Day 4). 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 10 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.