Evaluating SHR-2017 Injection for Osteoporosis in Postmenopausal Women
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
This study is testing a new injection called SHR-2017 to see if it is safe and effective for treating osteoporosis in women over 50.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. Industry-sponsored |
| Locations | 1 site (Jinan, Shangdong) |
| Trial ID | NCT05930704 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of SHR-2017, an injection administered subcutaneously, in postmenopausal women aged 50 and older. Participants will receive either the SHR-2017 injection or a placebo to determine the pharmacokinetics and pharmacodynamics of the treatment. The trial will involve monitoring for adverse effects and overall health responses following the injection. The study is designed to gather essential data that could inform future treatments for osteoporosis.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 50 years and older with a body mass index between 18.0 and 29.0 kg/m2.
Not a fit: Patients with a history of malignancy, bone metabolism diseases, or those currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for osteoporosis in postmenopausal women.
How similar studies have performed: While this specific approach is novel, similar studies evaluating new treatments for osteoporosis have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Postmenopausal women ages ≥ 50 years. 2. Body weight≥45 kg, body mass index (BMI) of 18.0 to 29.0 kg/m2 (inclusive). 3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF). Exclusion Criteria: 1. History of malignancy. 2. Menopause due to simple hysterectomy. 3. Subjects with poor blood pressure control. 4. Subjects with positive tests for infectious diseases. 5. Have a history of diseases related to bone metabolism. 6. Use of drugs that may affect bone metabolism before administration. 7. Have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening. 8. Female who are pregnant or breastfeeding. 9. Unable to tolerate venipunctures or have a history of fainting needles and blood. 10. Other reasons that the investigator consider it inappropriate to participate in the trial.
Where this trial is running
Jinan, Shangdong
- The First Affiliated Hospital of Shandong First Medical University — Jinan, Shangdong, China (Recruiting)
Study contacts
- Study coordinator: Yuanyuan Huang
- Email: yuanyuan.huang@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.