Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-2017 Injection in Postmenopausal Women

Study Overview
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Brief Summary
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The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: SHR-2017 injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR-2017 injection<br> | Drug: SHR-2017 injection<br>* Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Randomized participants will receive a single SC injection dose of matching placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | From day 1 up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration of SHR-2017 (Cmax) |  | 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 |  | 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 | 
| Percent change from baseline in serum Type I Collagen Carboxy-terminal Peptide (CTX) |  | Baseline 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 |