A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Healthy Subjects
概览
- 阶段
- 1 期
- 干预措施
- PHP-303
- 疾病 / 适应症
- Healthy Volunteer
- 发起方
- pH Pharma
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Plasma concentration of single oral dose of PHP-303 - t1/2
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in healthy volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 3:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability of orally-administered PHP-303.
研究者
入排标准
入选标准
- •Male or female subjects, ≥ 18 to ≤ 55 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.
研究组 & 干预措施
Experimental
PHP-303, single oral dose, up to 6 ascending dose cohorts
干预措施: PHP-303
Placebo
Placebo, single oral dose, up to 6 ascending dose cohorts
干预措施: Placebo
结局指标
主要结局
Plasma concentration of single oral dose of PHP-303 - t1/2
时间窗: Up to 9 weeks
Determination of half-life
Plasma concentration of single oral dose of PHP-303 - Cmax
时间窗: Up to 9 weeks
Maximum observed concentration
Safety and tolerability of single oral dose of PHP-303 - Incidence of Adverse Events
时间窗: Up to 9 weeks
Assess the number of patients with adverse events
Safety and tolerability of single oral dose of PHP-303 - blood pressure
时间窗: Up to 9 weeks
Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
Safety and tolerability of single oral dose of PHP-303 - number of patients with abnormal ECG
时间窗: Up to 9 weeks
Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
Safety and tolerability of single oral dose of PHP-303 - heart rate
时间窗: Up to 9 weeks
Measured as number of heart beats per minute
Safety and tolerability of single oral dose of PHP-303 - respiratory rate
时间窗: Up to 9 weeks
Measured by number of breaths per minute
Safety and tolerability of single oral dose of PHP-303 - body temperature
时间窗: Up to 9 weeks
Measurement of oral body temperature
Plasma concentration of single oral dose of PHP-303 - AUC
时间窗: Up to 9 weeks
Area under the curve