A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number and severity of TEAEs
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration.
Up to 72 healthy adult male subjects will be enrolled. Additional subjects may be enrolled (8 subjects per cohort) if it is deemed appropriate following review (e.g., in the circumstances where a dose level is repeated, or an intermediate dose is conducted or to add another dose level(s) (higher than those planned)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male 19-55 years of age, inclusive, at screening.
- •A continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to (the first) dosing and throughout the study, based on subject self-reporting.
- •Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
- •Medically healthy with no clinically significant medical history, physical examination, neurological examination, ophthalmic examination, clinical laboratory profiles, vital signs, or safety 12-lead ECGs, as deemed by the PI or designee.
- •A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after (the last) dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to (the first) dosing of the investigational product. A male who has been vasectomized less than 4 months prior to study (first) dosing must follow the same restrictions as a non-vasectomized male).
- •Must agree not to donate sperm from the first dosing until 90 days after the last dosing.
- •Able to swallow multiple capsules.
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •Is at suicidal risk in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
研究组 & 干预措施
MAD 5. FB-101 20mg QD
干预措施: FB-101 (Drug)
MAD 5. FB-101 20mg QD
干预措施: Placebo for FB-101 (Drug)
MAD 6. FB-101 30mg QD
干预措施: FB-101 (Drug)
MAD 8. FB-101 20mg BID
干预措施: FB-101 (Drug)
MAD 8. FB-101 20mg BID
干预措施: Placebo for FB-101 (Drug)
SAD 3. FB-101 40mg
干预措施: Placebo for FB-101 (Drug)
MAD 4. FB-101 10mg QD
干预措施: FB-101 (Drug)
SAD 2. FB-101 20mg
干预措施: FB-101 (Drug)
SAD 1. FB-101 10mg
干预措施: Placebo for FB-101 (Drug)
SAD 2. FB-101 20mg
干预措施: Placebo for FB-101 (Drug)
SAD 3. FB-101 40mg
干预措施: FB-101 (Drug)
MAD 6. FB-101 30mg QD
干预措施: Placebo for FB-101 (Drug)
MAD 7. FB-101 10mg BID
干预措施: FB-101 (Drug)
MAD 9. FB-101 30mg BID
干预措施: Placebo for FB-101 (Drug)
SAD 1. FB-101 10mg
干预措施: FB-101 (Drug)
MAD 4. FB-101 10mg QD
干预措施: Placebo for FB-101 (Drug)
MAD 7. FB-101 10mg BID
干预措施: Placebo for FB-101 (Drug)
MAD 9. FB-101 30mg BID
干预措施: FB-101 (Drug)
结局指标
主要结局
Number and severity of TEAEs
时间窗: up to 2 month
Number and severity of TEAEs following single ascending oral doses of FB-101 compared to placebo in healthy adult male subjects.
次要结局
未报告次要终点