The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Randomized participants of multiple dose cohorts will receive a single subcutaneous dose of SHR-2017 injection.
Randomized participants will receive a single SC injection dose of matching placebo.
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shangdong, China
RECRUITINGNumber of participants with adverse events
Time frame: From day 1 up to 9 months
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
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