A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
- To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
- To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
- To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health.
- •Age: 19 to 55 years inclusive at Screening.
- •Satisfies one of the following
- •Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR
- •Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
- •BMI: 18 to 30 kg/m2 at Screening.
排除标准
- •Clinically significant abnormalities in physical examination or vital signs.
- •Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- •Clinically significant screening laboratory result as assessed by the Investigator.
- •The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- •History or presence of malignancy with the past 5 years.
- •History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
- •Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort.
- •Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
- •Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment.
- •A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
- •Any clinically significant systemic infection within 3 weeks prior to screening.
- •Use of prescription medications within 30 days of screening.
研究组 & 干预措施
Cohort 3 /Dose level 3
Single dose orally: CAT-1004 Dose level 3 or placebo
干预措施: Placebo (Other)
Cohort 4/ Dose level 4
Single dose orally: CAT-1004 Dose level 4 or placebo
干预措施: Drug (Drug)
Cohort 4/ Dose level 4
Single dose orally: CAT-1004 Dose level 4 or placebo
干预措施: Placebo (Other)
Cohort 5/ Dose level 5
Single dose orally: CAT-1004 Dose level 5 or placebo
干预措施: Drug (Drug)
Cohort 1 / Dose level 1
Single dose orally: CAT-1004 Dose level 1 or placebo
干预措施: Drug (Drug)
Cohort 1 / Dose level 1
Single dose orally: CAT-1004 Dose level 1 or placebo
干预措施: Placebo (Other)
Cohort 2 / Dose level 2
Single dose orally: CAT-1004 Dose level 2 or placebo
干预措施: Drug (Drug)
Cohort 2 / Dose level 2
Single dose orally: CAT-1004 Dose level 2 or placebo
干预措施: Placebo (Other)
Cohort 3 /Dose level 3
Single dose orally: CAT-1004 Dose level 3 or placebo
干预措施: Drug (Drug)
Cohort 5/ Dose level 5
Single dose orally: CAT-1004 Dose level 5 or placebo
干预措施: Placebo (Other)
Cohort 2/ Dose level 2 ( FE)
Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo
干预措施: Drug (Drug)
Cohort 2/ Dose level 2 ( FE)
Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo
干预措施: Placebo (Other)
Cohort 3/ Dose level 3 (FE)
Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo
干预措施: Drug (Drug)
Cohort 3/ Dose level 3 (FE)
Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo
干预措施: Placebo (Other)
Cohort 6 / Dose level 6 (FE)
Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4.
干预措施: Drug (Drug)
Cohort 6 / Dose level 6 (FE)
Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4.
干预措施: Placebo (Other)
Cohort 7 / Dose level 7 (FE)
Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5.
干预措施: Drug (Drug)
Cohort 7 / Dose level 7 (FE)
Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5.
干预措施: Placebo (Other)
结局指标
主要结局
Safety
时间窗: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU
Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.
次要结局
- Pharmacokinetic Profile(Plasma blood samples through 72 hrs, urine collections through 48 hrs)