A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBS-008 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- RBP4 Pty Ltd
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
研究概览
简要总结
This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female, 18 to 65 years of age, inclusive, at screening.
- •The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- •The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
- •Female subjects must be of nonchildbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening; FSH level >40 mIU/mL). Female subjects may also be considered of non-childbearing if they have a confirmed medical condition which would deem the subject as infertile. E.g. MRKH Syndrome (Mullerian Agenesis) or another applicable condition.
- •Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or remain abstinent or agree to use a highly effective form of contraception when sexually active with a female partner for 90 days after study drug administration. Highly effective contraception requires use of a condom and appropriate contraceptive measures for your female partner (i.e. oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system). This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential.
- •The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, and weighs 50 to 100 kg (110 to 220 pounds), inclusive, at screening and check-in.
- •The subject is considered to be in stable health by the investigator.
- •The subject agrees to comply with all protocol requirements.
排除标准
- •Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
- •Vitamin A deficiency.
- •Any recent viral or bacterial infection.
- •Participated in any clinical study in last 6 weeks.
- •History of significant drug allergy
- •History of significant vision, ocular or retinal disorder.
- •Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
SAD - Cohort 1
50 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
SAD - Cohort 1
50 mg LBS-008 or placebo
干预措施: Placebos (Drug)
SAD - Cohort 2
100 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
SAD - Cohort 2
100 mg LBS-008 or placebo
干预措施: Placebos (Drug)
SAD - Cohort 3
200 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
SAD - Cohort 4
400 mg LBS-008 or placebo
干预措施: Placebos (Drug)
SAD - Cohort 3
200 mg LBS-008 or placebo
干预措施: Placebos (Drug)
SAD - Cohort 4
400 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
SAD - Cohort 5
25 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
SAD - Cohort 5
25 mg LBS-008 or placebo
干预措施: Placebos (Drug)
MAD - Cohort 1
10 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
MAD - Cohort 1
10 mg LBS-008 or placebo
干预措施: Placebos (Drug)
MAD - Cohort 2
25 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
MAD - Cohort 2
25 mg LBS-008 or placebo
干预措施: Placebos (Drug)
MAD - Cohort 3
5 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
MAD - Cohort 3
5 mg LBS-008 or placebo
干预措施: Placebos (Drug)
MAD - Cohort 4
12 mg LBS-008 or placebo
干预措施: LBS-008 (Drug)
MAD - Cohort 4
12 mg LBS-008 or placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Maximum observed plasma concentration (Cmax)
时间窗: SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28
Time to maximum observed plasma concentration (Tmax)
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal elimination rate constant
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal phase half-life (t1/2)
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent total body clearance (CL/F)
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent volume of distribution (Vz/F)
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation.
时间窗: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
次要结局
未报告次要终点