NCT05667129已完成1 期
A Phase 1 Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of XEN-101
Xeno Biosciences1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- The frequency of adverse events (Safety of XEN-101)
研究概览
简要总结
The goal of this study is to assess the safety and tolerability of single and multiple ascending doses of XEN-101
详细描述
Single ascending dose (SAD) study to evaluate the safety and tolerability of XEN-101 in healthy participants. Multiple ascending dose (MAD) study to evaluate the safety and tolerability of XEN-101 in healthy participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, age 18-60 years at Screening
- •SAD part: BMI 18-30 kg/m2; MAD part 2a: BMI 22-27 kg/m2; MAD Part 2b: BMI 30-40 kg/m2
- •Stable body weight for at least 3 months (fluctuation of less than or equal to 5% and not exceeding 4 kg) in all study Parts.
- •Women of childbearing potential shall agree to use an adequate method of contraception from the date of signing of the informed consent, throughout the study, and for 4 weeks after the final (EOS) study visit. In addition, they must be advised not to donate ova during this period. From the date of signing of the informed consent, throughout the study, and for 8 weeks after the last dose of study medication, non sterilized male subjects who are sexually active with a female partner of childbearing potential must use barrier contraception (e.g., condom with spermicidal cream or jelly). In addition, they must be advised not to donate sperm during this period.
- •Females of childbearing potential must have a negative pregnancy test at Screening and on Day -1 (baseline)
- •Able to provide Informed Consent
- •Willing and able to comply with this protocol and procedures, including feces pro-cessing and be available for the entire duration of the study.
排除标准
- •Currently enrolled in another investigational device or drug study, or less than 30 days or 5 time the half-life of the drug candidate, whichever is longer, passed at Screening since ending the treatment period the previous investigational device or drug study
- •History of diabetes mellitus, hypertension, sleep apnea, liver, kidney, auto-immune disease
- •Current nicotine use or in past 6 months (smoking, vaping, etc)
- •Uncontrolled psychiatric disorder
- •History of eating disorder (e.g. anorexia nervosa, bulimia, binge-eating disorder)
- •History of alcohol, nicotine, or substance misuse in the last 5 years
- •Use of antibiotics, antivirals, antifungals during past 3 months
- •Use of proton pump inhibitors or non-stable dose antidepressants
- •Use of anti-obesity medications (e.g. GLP-analogues, stimulants, bupropri-on/naltrexone, etc.)
- •Use of obesogenic medications (e.g. anti-diabetics, anti-convulsives, anti-histamines, beta-blockers, etc.) in past 3 months
研究组 & 干预措施
XEN-101
Experimental
Capsule formulation
干预措施: XEN-101 (Drug)
Placebo
Placebo Comparator
Capsule formulation
干预措施: Placebo (Drug)
结局指标
主要结局
The frequency of adverse events (Safety of XEN-101)
时间窗: From Day 1 through end of study (Day 7 SAD; Day 38 MAD)
assessing the type and frequency of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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