OsteoporosisPhase 1NCT04435158
A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients
A Phase 1 study testing SHR-1222 in people with Osteoporosis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SHR-1222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2020to 18 Jul 2022
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Age ≥50 and ≤70 years old and post menopause for at least 5 years at the time of screening;
- Weight ≥40kg at the time of screening;
- BMD T-score ≤ -2.50 at the lumbar vertebrae, total hip or femoral neck at the time of screening, based on DXA scans;
- At least 2 vertebrae in the L1-L4 region and at least one hip are evaluable by DXA;
- Without disease that would significantly affect the study or bring additional health risks at the time of screening or baseline; blood pressure < 150 / 95mmHg, blood fasting blood glucose < 7.0mmol/l, glycosylated hemoglobin < 7%, or total cholesterol < 6.2mmol/l, triglyceride < 3.4mmol/l under the condition of lifestyle improvement rather than drug treatment; If there are other abnormalities in the examination report of the subject, the subject could only be included after investigator approval;
- Ambulatory.
Who cannot join
- Any disease affecting bone metabolism;
- Any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures, as assessed by the central imaging based on lateral spine x-rays at the time of screening;
- History of hip fracture;
- 25 (OH) vitamin D levels < 20 ng/mL at the time of screening. Vitamin D repletion will be permitted and subjects may be rescreened;
- BMD T-score < -3.50 at the lumber vertebra, total hip or femoral neck at the time of screening, based on DXA scans;
- Use of the following agents affecting bone metabolism:
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- IV bisphosphonates or denosumab prior to screening;
- Oral bisphosphonates, PTH analogs, Strontium or fluoride within 12m prior to screening;
- Hormone replacement therapy within 6m prior to screening;
- Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed), Anabolic steroids, Calcitriol and available analogues, thiazide diuretics within 3m prior to screening;
- History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as hyperprolactinemia, osteosclerosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome;
- Hyperparathyroidism, hypothyroidism, hyperthyroidism, hypothyroidism, hypercalcemia, hypocalcemia, renal failure, etc at the time of screening;
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years;
- A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
- Past medical history of cerebral infarction, ischemic or hemorrhagic stroke;
- Past medical history of Myocardial infarction, coronary heart disease, angina pectoris, heart failure (cardiac function II-IV), serious arrhythmia (such as atrial fibrillation, pacemaker needed)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT) or total bilirubin, more than 2 x ULN during screening;
- 3 months prior to screening involved in any drug clinical subjects (except screening failed or not given cinical drugs) or within 5 half-lives of test drug at the time of screening;
- Any major surgery in 1m prior to screening or a surgery plan during the study;
- Blood donation or loss more than 400mL or blood transfusion within 3 months prior to screening;
- Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were positive;
- No history of alcohol and substance abuse or positive urine drug screening;
- Subjects with any other situation should not be involved, which determined by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Xiangya Hospital , Chinese Academy of Medical Sciences
Changsha, Hunan
About this study
Official title: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Study Following Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients
This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients.
The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in postmenopausal osteoporosis patients including assessment of immunogenicity.
- Conditions
- Osteoporosis
- Being tested
- SHR-1222, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1222Drug
Pharmaceutical form: water injection Route of administration: subcutaneous injection
PlaceboDrug
Pharmaceutical form: water injection Route of administration: subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1：SHR-1222 | Experimental | Subcutaneous injection of SHR-1222 dosage 1 monthly × 6 months Receives: Drug: SHR-1222 |
| Cohort 2：SHR-1222 | Experimental | Subcutaneous injection of SHR-1222 dosage 2 monthly × 6 months Receives: Drug: SHR-1222 |
| Cohort 3：SHR-1222 | Experimental | Subcutaneous injection of SHR-1222 dosage 3 monthly × 6 months Receives: Drug: SHR-1222 |
| Cohort 4：SHR-1222 | Experimental | Subcutaneous injection of SHR-1222 dosage 4 every 2 months × 6 months Receives: Drug: SHR-1222 |
| Cohort 5：SHR-1222 | Experimental | Subcutaneous injection of SHR-1222 dosage 5 every 2 months × 6 months Receives: Drug: SHR-1222 |
| Cohort 6：placebo | Experimental | Subcutaneous injection of placebo × 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerance: Number of subjects with adverse events
Number \& proportion of subjects with adverse events
Measured: Dose administration to 225 days after first dose administration
Secondary outcomes (13)
Assessment of PK parameter-time to maximum concentration (Tmax)
Measured: Pre-dose to 225 days after first dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Measured: Pre-dose to 225 days after first dose administration
Assessment of PK parameter-area under curve (AUC)
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in serum C-telopeptide (sCTx) from baseline
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in aminoterminal propeptide type-1 procollagen (P1NP) from baseline
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in osteocalcin from baseline
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in bone-specific alkaline phosphatase (BSAP) from baseline
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in serum totol sclerostin
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of lumbar spine (L1-L4) from baseline by dualenergy X-ray absorptiometry
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of collum femoris from baseline by dualenergy X-ray absorptiometry
Measured: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of total hip from baseline by dualenergy X-ray absorptiometry
Measured: Pre-dose to 225 days after first dose administration
Antidrug antibody
Measured: Pre-dose to 225 days after first dose administration
Neutralizing Antibody
Measured: Pre-dose to 225 days after first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start25 Aug 2020
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
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.
- More trials run by Jiangsu HengRui Medicine 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhiguang Zhou, Principal investigator, 2nd Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435158
- Sponsor's protocol ID
- SHR-1222-102
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2020
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Study Following Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients
- ClinicalTrials.gov ID
- NCT04435158
- Acronym / sponsor ID
- SHR-1222-102
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 17 Jun 2020 (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 Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in Postmenopausal Osteoporosis Patients.
The primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in postmenopausal osteoporosis patients including assessment of immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1：SHR-1222 | Experimental | Drug: SHR-1222Subcutaneous injection of SHR-1222 dosage 1 monthly × 6 months |
| Cohort 2：SHR-1222 | Experimental | Drug: SHR-1222Subcutaneous injection of SHR-1222 dosage 2 monthly × 6 months |
| Cohort 3：SHR-1222 | Experimental | Drug: SHR-1222Subcutaneous injection of SHR-1222 dosage 3 monthly × 6 months |
| Cohort 4：SHR-1222 | Experimental | Drug: SHR-1222Subcutaneous injection of SHR-1222 dosage 4 every 2 months × 6 months |
| Cohort 5：SHR-1222 | Experimental | Drug: SHR-1222Subcutaneous injection of SHR-1222 dosage 5 every 2 months × 6 months |
| Cohort 6：placebo | Experimental | Drug: PlaceboSubcutaneous injection of placebo × 6 months |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Age ≥50 and ≤70 years old and post menopause for at least 5 years at the time of screening;
- Weight ≥40kg at the time of screening;
- BMD T-score ≤ -2.50 at the lumbar vertebrae, total hip or femoral neck at the time of screening, based on DXA scans;
- At least 2 vertebrae in the L1-L4 region and at least one hip are evaluable by DXA;
Key exclusion criteria (23 listed)
- Any disease affecting bone metabolism;
- Any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures, as assessed by the central imaging based on lateral spine x-rays at the time of screening;
- History of hip fracture;
- 25 (OH) vitamin D levels < 20 ng/mL at the time of screening. Vitamin D repletion will be permitted and subjects may be rescreened;
- BMD T-score < -3.50 at the lumber vertebra, total hip or femoral neck at the time of screening, based on DXA scans;
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 |
|---|---|---|
| SHR-1222Pharmaceutical form: water injection Route of administration: subcutaneous injection | Drug | Cohort 1：SHR-1222, Cohort 2：SHR-1222, Cohort 3：SHR-1222, Cohort 4：SHR-1222, Cohort 5：SHR-1222 |
| PlaceboPharmaceutical form: water injection Route of administration: subcutaneous injection | Drug | Cohort 6：placebo |
Primary outcome
Safety and Tolerance: Number of subjects with adverse events
Time frame: Dose administration to 225 days after first dose administration
Number \& proportion of subjects with adverse events
13 secondary outcomes
Assessment of PK parameter-time to maximum concentration (Tmax)
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PK parameter-maximum concentration (Cmax)
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PK parameter-area under curve (AUC)
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in serum C-telopeptide (sCTx) from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in aminoterminal propeptide type-1 procollagen (P1NP) from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in osteocalcin from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in bone-specific alkaline phosphatase (BSAP) from baseline
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in serum totol sclerostin
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of lumbar spine (L1-L4) from baseline by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of collum femoris from baseline by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 225 days after first dose administration
Assessment of PD parameter-change in areal bone mineral density of total hip from baseline by dualenergy X-ray absorptiometry
Time frame: Pre-dose to 225 days after first dose administration
Antidrug antibody
Time frame: Pre-dose to 225 days after first dose administration
Neutralizing Antibody
Time frame: Pre-dose to 225 days after first dose administration
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 6 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Zhiguang Zhou principal investigator
2nd 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 SHR-1222 in people with Osteoporosis, run by Jiangsu HengRui Medicine 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 7 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: finished, as of the sponsor's last update on 6 Jul 2023. 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?
Safety and Tolerance: Number of subjects with adverse events (time frame: Dose administration to 225 days after first dose administration). 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 6 Jul 2023.