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临床试验/NCT03627845
NCT03627845
已完成
1 期

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

pH Pharma1 个研究点 分布在 1 个国家目标入组 49 人2018年8月2日
干预措施PHP-303Placebo
相关药物PHP-303

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.

注册库
clinicaltrials.gov
开始日期
2018年8月2日
结束日期
2020年1月8日
最后更新
6年前
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

发起方
pH Pharma
责任方
Sponsor

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

研究点 (1)

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