Osteoporosis
Conditions
Brief summary
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
Interventions
DRUGSHR-2017 injection
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
DRUGPlacebo
Randomized participants will receive a single SC injection dose of matching placebo.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | From day 1 up to 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of SHR-2017 | Day 1 pre-dose up to Day 253 |
| Time to maximum observed concentration (Tmax) of SHR-2017 | Day 1 pre-dose up to Day 253 |
| Percent change from baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr) | Baseline up to Day 253 |
| Maximum observed concentration of SHR-2017 (Cmax) | Day 1 pre-dose up to Day 253 |
| Percent change from baseline in Intact Parathyroid Hormone (iPTH) | Baseline up to Day 253 |
| Percent change from baseline in Bone-Specific Alkaline Phosphatase (BALP) | Baseline up to Day 253 |
| Number of subjects who developed SHR-2017 antidrug antibodies (ADA) | Baseline up to Day 253 |
| Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX) | Baseline up to Day 253 |
Countries
China
Contacts
Primary ContactYuanyuan Huang
Outcome results
None listed