NCT05930704招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
The primary objective was to evaluate the safety and tolerability of SHR-2017 after a single subcutaneous (SC) injection in postmenopausal women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
SHR-2017 injection
Experimental
干预措施: SHR-2017 injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From day 1 up to 9 months
次要结局
- 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)
- Maximum observed concentration of SHR-2017 (Cmax)(Day 1 pre-dose 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 Urinary N-Telopeptide Corrected for Urine Creatinine (uNTx/Cr)(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)
- Time to maximum observed concentration (Tmax) of SHR-2017(Day 1 pre-dose up to Day 253)
- Percent change from baseline in Intact Parathyroid Hormone (iPTH)(Baseline up to Day 253)
研究者
研究点 (1)
Loading locations...
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