NCT05317013终止1 期
A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Preliminary Effects of CHI-554 in Postmenopausal Women With Osteopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safety and Tolerability: Aspartate aminotransferase (AST)
研究概览
简要总结
This is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is a female aged 50-80 years, inclusive, at the time of screening.
- •Is postmenopausal, defined as > or = 12 months amenorrhoea.
- •Has osteopenia, defined as T score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (DXA) completed at the Screening Visit or performed at NM Clinical Research & Osteoporosis Center up to 6 months prior to the Screening Visit.
- •Has been on a stable dose of 500 mg calcium daily for at least 7 days prior to Visit
- •Has a body mass index between 18 and 35 kg/m2 (inclusive).
- •Is judged by the Investigator to be in generally good health at screening based on participants' medical history.
- •Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
排除标准
- •Has a history of epilepsy, hepatitis, or human immunodeficiency virus.
- •Current or history of use of one or more prohibited medications (as described in Section 8.2.1.1).
- •Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the Screening Visit.
- •Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal (ULN), or bilirubin >2× ULN.
- •Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
- •Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).
- •Has taken grapefruit products and/or Seville oranges within the 7 days prior to Visit
- •Positive urine dipstick results for THC at the Screening Visit.
- •Has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.
- •Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
- •Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
- •History of Osteoporosis diagnosis.
研究组 & 干预措施
Group A - 100 mg CBD
Experimental
100 mg CBD per day
干预措施: CBD (Drug)
Group B - 300 mg CBD
Experimental
300 mg CBD per day
干预措施: CBD (Drug)
Group C - Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Safety and Tolerability: Aspartate aminotransferase (AST)
时间窗: Week 12
Aspartate aminotransferase
Safety and Tolerability: Adverse Events/Serious Adverse Events
时间窗: Week 12
Adverse Events/Serious Adverse Events
Safety and Tolerability: Alanine aminotransferase (ALT)
时间窗: Week 12
Alanine aminotransferase
Safety and Tolerability: Total bilirubin
时间窗: Week 12
Total bilirubin
Safety and Tolerability: Blood pressure
时间窗: Week 12
Blood pressure - Systolic and diastolic blood pressure
Safety and Tolerability: Heart rate
时间窗: Week 12
Heart rate
次要结局
- Serum P1NP(Week 12)
- Serum CTx(Week 12)
- Serum Osteocalcin(Week 12)
- Serum Bone-specific alkaline phosphatase(Week 12)
研究者
研究点 (1)
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