NCT07675590招募中1 期
A Single Center, Multiple Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
TIXiMED, Inc.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 18-70 years, both genders.
- •Healthy as determined by the Investigator, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following:
- •Absence of clinically significant illness or surgery within the preceding 12 weeks.
- •Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
- •Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
- •Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use double-barrier contraception during the study. The primary contraception may be oral contraceptives, hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide.
- •Female subjects of non-child-bearing potential (i.e. bilateral tubal ligation (BTL), bilateral tubal occlusion (BTO), bilateral salpingectomy, hysterectomy, partial hysterectomy, bilateral oophorectomy, or postmenopausal, defined as no menses for 12 months without an alternative medical cause).
- •Body mass index (BMI) 25 - 34.9 kg/m2
- •HbA1c <6.5%
- •Willingness to fully comply with protocol.
排除标准
- •History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen.
- •Pregnant or breastfeeding within six months of screening assessment.
- •Substantial changes in eating habits or exercise routines within the preceding three months.
- •Evidence of eating disorders.
- •>5% weight change in the past three months.
- •Bariatric surgery within the past five years.
- •Significant renal impairment (eGFR <60 mL/min/1.73m2).
- •Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
- •Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
- •Use of prescription medications during screening and duration of the trial.
- •Use of drugs approved for the treatment of obesity.
- •Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
- •A baseline prolongation of QT/QTcF interval after repeated measurements of >450 ms for men and >470 for women; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS.
- •Participation in an investigational drug trial within three months prior to dosing in the present study.
结局指标
主要结局
Safety and Tolerability
时间窗: Day 1 to Day 35
* Number of subjects with Treatment-Emergent Adverse Events (TEAEs) * Number of subjects with clinically significant TEAEs (Physical Examination, Vital Signs, ECG)
次要结局
- Pharmacokinetic: Area Under Concentration (AUC)(Day 1 and Day 28)
研究者
研究点 (1)
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