A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Count of Participants With Adverse Events
研究概览
简要总结
This will be a randomized, double-blind, placebo-controlled, dose-escalation study of 3 dose levels of LMN-101. Healthy volunteers will take LMN-101 or placebo orally either as a single dose or at one of three dose levels three times daily over 28 days. Protocol-specified evaluations and procedures will be performed on Days 1-2 and every one-two weeks during dosing. Study observation will continue until 4 weeks after the last dose of study drug.
详细描述
Healthy volunteers will be sequentially assigned to the following dosing regimens:
Part A:
A single, open-label dose of 3000 mg orally (2 subjects)
Part B:
Subjects will be randomized within a dose regimen to active or placebo treatment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part B: Identical-appearing placebo
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 50 years, inclusive, at time of informed consent
- •Willingness to participate after written informed consent obtained
- •Available for all planned clinical visits for physical examinations, blood draws, stool collections
- •General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
- •Adequate bone marrow reserve, renal and liver function.
- •Absolute neutrophil count ≥ 1.5 x 10e9/L
- •Lymphocyte count < 6.0 x 10e9/L
- •Platelet count ≥ 150 x 10e9/L
- •Hemoglobin ≥ 110 g/L
- •Estimated glomerular filtration rate ≥ 40 mL/min/1.73 meter squared
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5x ULN
- •Serum albumin ≥ 28 g/L
- •Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
- •Sexual abstinence (inactivity) or exclusively same-sex partner for 1 month prior to screening through study completion; or
- •Intrauterine device (IUD) in place for at least 1 month prior to study through study completion; or
- •Stable hormonal contraception for at least 1 month prior to study through study completion; or
- •Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
- •To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses.
- •Male participants must use condoms during the study and through study completion.
排除标准
- •Treatment with an experimental compound within 30 days.
- •Treatment within 30 days or planned use within the study period with immunomodulator or immunosuppressant agent.
- •Pregnancy or breastfeeding.
- •Presence of any of the following clinical conditions:
- •History of one or more of the following: cardiac insufficiency (NYHA III/IV), uncontrolled cardiac arrhythmias, unstable ischemic heart disease, or uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 110 mmHg).
- •History of venous thromboembolic disease within 12 months, myocardial infarction, or cerebrovascular accident.
- •Unstable pulmonary, renal, hepatic, endocrine or hematologic disease.
- •Gastrointestinal disorder requiring ongoing care by a physician.
- •Autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
- •Evidence of active malignant disease, malignancies diagnosed within the previous 5 years, or breast cancer diagnosed within the previous 5 years (except skin cancers other than melanoma).
- •Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks.
- •Positive serology for human immunodeficiency virus (HIV) infection or history of other immunodeficiency illness.
- •Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •Significant neuromuscular disease or neuropathy
- •Psychiatric condition
- •Alcohol or illicit drug abuse/dependency or positive urine toxicology screen for drugs of abuse other than marijuana. Alcohol and tobacco consumption are permitted.
研究组 & 干预措施
Part B: Cohort 1
300 mg PO TID given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days
干预措施: LMN-101 (Biological)
Part B: Cohort 2
1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days
干预措施: LMN-101 (Biological)
Part B: Cohort 3
3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days
干预措施: LMN-101 (Biological)
Part A
3000 mg PO single dose given as six 500-mg capsules of LMN-101 orally
干预措施: LMN-101 (Biological)
结局指标
主要结局
Count of Participants With Adverse Events
时间窗: Day 1 to Day 56
Counts of participants with adverse events
次要结局
未报告次要终点