A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.
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
- 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 subjects, ≥ 18 to ≤ 60 years of age.
- •In good general health having no clinically significant diseases in medical history or evidence of clinically significant findings on physical examination, vital signs, laboratory results, and/or ECG at Screening, in the opinion of an Investigator.
- •Willing to forego other forms of experimental treatment during the study.
排除标准
- •Any clinically significant condition that, in the opinion of an Investigator, could preclude the safe participation of the subject in the study or would prevent the subject from meeting the study requirements.
- •Major surgery in the 6 months preceding Screening.
- •Clinically-significant abnormal laboratory parameters.
- •Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine, tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening or on admission to the study site.
- •Electrocardiographic Fridericia's corrected QT interval (QTcF) interval > 450 msec for males and > 470 msec for females, or any other clinically significant electrocardiographic abnormality.
- •Blood pressure results > 150 mmHg systolic or > 95 mmHg diastolic
- •Female subject who is pregnant (positive pregnancy test at the Screening Visit or on admission to the study site), lactating, or planning to become pregnant during the study period or within 3 months after the final dose of study medication.
- •History of drug or alcohol abuse or dependence within 1 year prior to Screening.
- •History of cigarette smoking within 3 months of Screening.
- •Known intolerance to lactose.
- •Regular use of prescription drugs within 14 days of the first administration of study drug or non-prescription (over-the-counter) drugs within 7 days of the first administration of study drug or unwilling to abstain from prohibited medications through the end of study.
研究组 & 干预措施
Experimental
PHP-303, multiple oral dose, up to 5 ascending dose cohorts
干预措施: PHP-303 (Drug)
Placebo
Placebo, multiple oral dose, up to 5 ascending dose cohorts
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
时间窗: Up to 12 weeks
Assess the number of patients with adverse events
Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
时间窗: Up to 12 weeks
Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
时间窗: Up to 12 weeks
Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Safety and tolerability of multiple oral doses of PHP-303 - heart rate
时间窗: Up to 12 weeks
Measured as number of heart beats per minute
Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
时间窗: Up to 12 weeks
Measured by number of breaths per minute
Plasma concentration of multiple oral doses of PHP-303 - AUC
时间窗: Plasma Up to 12 weeks
Area under the curve
Plasma concentration of multiple oral doses of PHP-303 - t1/2
时间窗: Up to 12 weeks
Determination of half-life
Safety and tolerability of multiple oral doses of PHP-303 - body temperature
时间窗: Up to 12 weeks
Measurement of oral body temperature
Plasma concentration of multiple oral doses of PHP-303 - Cmax
时间窗: Up to 12 weeks
Maximum observed concentration
Plasma concentration of multiple oral doses of PHP-303 - Tmax
时间窗: Up to 12 weeks
Time to reach maximum measured plasma concentration
次要结局
未报告次要终点