NCT03062618已完成1 期
Randomized, Double Blind, Placebo Controlled, Incomplete Crossover Single Oral Dose Escalation of PRCL-02 in Normal Healthy Volunteers (Part A) and Multiple Oral Dose Escalation in Normal Healthy Volunteers (Part B) and in Chronic Plaque Psoriasis Patients (Part C)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Number of Participants with One or More Serious Adverse Events (Part A)
研究概览
简要总结
This study consists of three parts: single oral dose escalation in healthy volunteers (Part A), and multiple oral dose escalations in healthy volunteers (Part B) and in participants with chronic plaque psoriasis (Part C)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parts A and B
- •Be 18 to 55 years old
- •Be healthy with absence of clinically significant illness
- •Male participants must agree to use medically accepted methods of contraception with all sexual partners during the study, and for 90 days after
- •Female participants must be postmenopausal or surgically sterile
- •Have venous access sufficient for blood sampling
- •Be a non-smoker
- •Be 18 to 75 years old
- •Have chronic plaque psoriasis based on a confirmed diagnosis of plaques for at least 6 months
- •Have at least 2 evaluable plaques located in at least 2 body regions
排除标准
- •Parts A and B
- •Significant abnormalities in vital signs, laboratory tests, electrocardiogram, or history of heart disease, some allergies, or infections
- •Hepatic or renal impairment
- •Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)
- •Female participants who are pregnant or breast feeding
- •Recent or ongoing infection
- •History of alcohol or drug abuse
- •Current or recent enrollment in a clinical trial judged not compatible with this study
- •Have highly active psoriatic arthritis
- •Have pustular, erythrodermic and/or guttate forms of psoriasis
- •Have had a clinically-significant flare of psoriasis during the last 12 weeks
- •Currently or recently taking certain prescribed therapies for psoriasis
- •Use of selected topical treatments within 4 weeks prior to starting the study (use of some emollients without urea is allowed, except on one lesion for biopsy)
研究组 & 干预措施
Part C: Multiple Dose
Experimental
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
干预措施: PRCL-02 (Drug)
Part A: Single Dose
Experimental
Two escalating sequences of single oral doses of PRCL-02, in 3 periods, starting at 4 milligrams (mg)
干预措施: PRCL-02 (Drug)
Part A: Single Dose (Placebo)
Placebo Comparator
Two escalating sequences of matching placebo oral tablets, in 3 periods
干预措施: Placebo Oral Tablet (Drug)
Part B: Multiple Dose
Experimental
Multiple oral doses of PRCL-02 for 28 days, at up to 3 dose levels
干预措施: PRCL-02 (Drug)
Part B: Multiple Dose (Placebo)
Placebo Comparator
Multiple oral doses of placebo for 28 days, at matching dose levels
干预措施: Placebo Oral Tablet (Drug)
Part C: Multiple Dose (Placebo)
Placebo Comparator
Multiple oral doses of placebo for 28 days, at matching dose levels
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Events (Part A)
时间窗: Baseline up to approximately 45 days
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
Number of Participants with One or More Serious Adverse Events (Part C)
时间窗: Baseline up to approximately 73 days
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
Number of Participants with One or More Serious Adverse Events (Part B)
时间窗: Baseline up to approximately 50 days
Number of participants with a serious adverse event, regardless of causality, by dose and treatment
次要结局
- Maximum Observed Drug Concentration (Cmax) in Part C(Baseline up to approximately 31 days)
- Time to Maximum Drug Concentration (Tmax) in Part A(Baseline up to approximately 29 days)
- Change from Baseline in Triplicate 12-lead Electrocardiogram (ECG) in Part A(Baseline up to 24 hours post-dose on day 2)
- Change in Baseline in Triplicate 12-lead ECG in Part B(Baseline up to 24 hours post-dose on day 6)
- Change in Baseline in Triplicate 12-lead ECG in Part C(Baseline up to approximately day 28)
- Change from Baseline in Single 12-Lead ECG in Part A(Baseline up to approximately 45 days)
- Change from Baseline in Single 12-Lead ECG in Part B(Baseline up to approximately 50 days)
- Change from Baseline in Single 12-Lead ECG in Part C(Baseline up to approximately 73 days)
- Number of Participants With Clinically Significant Changes in Vital Signs in Part A(Baseline up to approximately 45 days)
- Number of participants with Laboratory Test Results outside of reference range in Part B(Baseline up to approximately 50 days)
- Number of participants with Laboratory Test Results outside of reference range in Part C(Baseline up to approximately 73 days)
- Maximum Observed Drug Concentration (Cmax) in Part A(Baseline up to approximately 29 days)
- Maximum Observed Drug Concentration (Cmax) in Part B(Baseline up to approximately 33 days)
- Number of Participants With Clinically Significant Changes in Vital Signs in Part B(Baseline up to approximately 50 days)
- Number of Participants With Clinically Significant Changes in Vital Signs in Part C(Baseline up to approximately 73 days)
- Number of participants with Physical Examination Findings in Part A(Baseline up to approximately 45 days)
- Number of participants with Physical Examination Findings in Part B(Baseline up to approximately 50 days)
- Number of participants with Physical Examination Findings in Part C(Baseline up to approximately 73 days)
- Number of participants with Laboratory Test Results outside of reference range in Part A(Baseline up to approximately 45 days)
- Time to Maximum Drug Concentration (Tmax) in Part B(Baseline up to approximately 33 days)
- Time to Maximum Drug Concentration (Tmax) in Part C(Baseline up to approximately 31 days)
- Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-∞) in Part A(Baseline up to approximately 29 days)
- Area Under the Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part B(Baseline up to approximately 33 days)
- Area Under The Plasma Concentration-Time Curve During the Dosing Interval (24h) (AUC0-tau) in Part C(Baseline up to approximately 31 days)
- Minimum or Trough Concentration (Cmin)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Lag Time: Time Delay Between Drug Administration and First Observed Plasma Concentration (Tlag)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Elimination Rate (Ke)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Terminal Elimination Half-Life (t1/2)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Area Under the Plasma Concentration Time Curve from Time Zero to 24 Hours Post-dose (AUC0-24)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Area Under the Plasma Concentration Time Curve from Time Zero to the Last Observed Time Point (AUC0-t)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Apparent Clearance (CL/F)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Apparent Volume of Distribution (Vd/F)(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
- Accumulation Ratio(Predose up to approximately 29 days (Part A); 33 days (Part B), 31 days (Part C))
研究者
研究点 (6)
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