OsteoporosisPhase 1NCT05930704
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women
A Phase 1 study testing SHR-2017 injection in people with Osteoporosis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- SHR-2017 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to 12 Apr 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women ages ≥ 50 years.
- Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).
- Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Who cannot join
- History of malignancy.
- Menopause due to simple hysterectomy.
- Subjects with poor blood pressure control.
- Subjects with positive tests for infectious diseases.
- Have a history of diseases related to bone metabolism.
- Use of drugs that may affect bone metabolism before administration.
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- Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening.
- Female who are pregnant or breastfeeding.
- Unable to tolerate venipunctures or have a history of fainting needles and blood.
- Other reasons that the investigator consider it inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shangdong, 250000
Wei Zhao
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection Administered Subcutaneously to Postmenopausal Women
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
- Conditions
- Osteoporosis
- Being tested
- SHR-2017 injection, 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-2017 injectionDrug
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
PlaceboDrug
Randomized participants will receive a single SC injection dose of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-2017 injection | Experimental | Not described Receives: Drug: SHR-2017 injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: From day 1 up to 9 months
Secondary outcomes (8)
Maximum observed concentration of SHR-2017 (Cmax)
Measured: Day 1 pre-dose up to Day 253
Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017
Measured: Day 1 pre-dose up to Day 253
Time to maximum observed concentration (Tmax) of SHR-2017
Measured: Day 1 pre-dose up to Day 253
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)
Measured: Baseline up to Day 253
Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)
Measured: Baseline up to Day 253
Percent change from baseline in Intact Parathyroid Hormone (iPTH)
Measured: Baseline up to Day 253
Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)
Measured: Baseline up to Day 253
Number of subjects who developed SHR-2017 antidrug antibodies (ADA)
Measured: Baseline up to Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start4 Jul 2023
- Primary completion12 Apr 2025 (estimated)
- Study completion12 Apr 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.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930704
- Sponsor's protocol ID
- SHR-2017-101
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 17 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection Administered Subcutaneously to Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05930704
- Acronym / sponsor ID
- SHR-2017-101
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 12 Apr 2025 (estimated)
- Study completion
- 12 Apr 2025 (estimated)
- First posted
- 5 Jul 2023 (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.
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-2017 injection | Experimental | Drug: SHR-2017 injection |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women ages ≥ 50 years.
- Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive).
- Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).
Key exclusion criteria (10 listed)
- History of malignancy.
- Menopause due to simple hysterectomy.
- Subjects with poor blood pressure control.
- Subjects with positive tests for infectious diseases.
- Have a history of diseases related to bone metabolism.
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-2017 injectionRandomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection. | Drug | SHR-2017 injection |
| PlaceboRandomized participants will receive a single SC injection dose of matching placebo. | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: From day 1 up to 9 months
8 secondary outcomes
Maximum observed concentration of SHR-2017 (Cmax)
Time frame: Day 1 pre-dose up to Day 253
Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017
Time frame: Day 1 pre-dose up to Day 253
Time to maximum observed concentration (Tmax) of SHR-2017
Time frame: Day 1 pre-dose up to Day 253
Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)
Time frame: Baseline up to Day 253
Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX)
Time frame: Baseline up to Day 253
Percent change from baseline in Intact Parathyroid Hormone (iPTH)
Time frame: Baseline up to Day 253
Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP)
Time frame: Baseline up to Day 253
Number of subjects who developed SHR-2017 antidrug antibodies (ADA)
Time frame: Baseline up to Day 253
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
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-2017 injection in people with Osteoporosis, run by Suzhou Suncadia Biopharmaceuticals 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 10 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 17 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. 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 Yuanyuan Huang (0518-82342973, yuanyuan.huang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: From day 1 up to 9 months). 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 17 Jul 2023.