Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 7
- 主要终点
- Safety of multiple, ascending dose levels of MTX-101
研究概览
简要总结
First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.
详细描述
A Phase 1, Part A -prospective, randomized, single-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA). Part B - A multi-center, randomized, open-label study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in participants with type 1 diabetes (T1D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, 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
- •Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing (Day 1).
- •Healthy individuals without known current or chronic medical conditions, including no history of any autoimmune diseases, in the opinion of the Investigator.
- •Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 AND body weight ≥ 55 and ≤ 120 kg.
- •Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to each dose.
- •Persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from Day 1 through the duration of the study.
排除标准
- •Clinically significant findings in physical examination (PE), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ECG), and safety laboratory parameters at Screening in the opinion of the Investigator.
- •Prior or concurrent malignancies.
- •Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of Screening.
- •Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
- •Receipt of an investigational drug within 28 days or 5 half-lives (whichever is longer) of the investigational drug(s) prior to Day
- •Positive serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis (Hep) B surface antigen, or Hep C.
- •Positive test results for drug screen, including alcohol, at the time of Screening or on Day 1 prior to randomization.
- •Use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/week within 30 days prior to (first) dosing.
- •Participants must abstain from nicotine use while inpatient.
- •History of receiving a live vaccine within 1 month of Screening.
- •History of splenectomy.
- •History of COVID or influenza vaccine within 2 weeks prior to Screening.
- •Planning to receive any vaccinations during the study period.
- •History of recurrent infections of uncertain cause.
研究组 & 干预措施
Cohort AS1 - Healthy Volunteers
(n = 6): MTX-101, Dose level 1 IV or Placebo IV, Single dose
干预措施: Placebo (Drug)
Cohort AS2 - Healthy Volunteers
(n = 6): MTX-101, Dose Level 2 IV or Placebo IV, Single dose
干预措施: Placebo (Drug)
Cohort AS3 - Healthy Vounteers
(n = 6): MTX-101, Dose Level 3 IV or Placebo IV, single dose
干预措施: Placebo (Drug)
Cohort AS4 - Healthy Volunteers
(n =6): MTX-101, Dose Level 4 IV or Placebo IV, single dose
干预措施: Placebo (Drug)
Cohort AS5 - Healthy Volunteers
(n = 6): MTX-101, Dose level 6 IV or Placebo IV, Single Dose
干预措施: Placebo (Drug)
Cohort AM1 - Healthy Volunteers
Cohort AM1 (n = 6): MTX-101, Dose Level 5 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses
干预措施: Placebo (Drug)
Cohort AS1 - Healthy Volunteers
(n = 6): MTX-101, Dose level 1 IV or Placebo IV, Single dose
干预措施: MTX-101 (Drug)
Cohort AS4 - Healthy Volunteers
(n =6): MTX-101, Dose Level 4 IV or Placebo IV, single dose
干预措施: MTX-101 (Drug)
Cohort AS2 - Healthy Volunteers
(n = 6): MTX-101, Dose Level 2 IV or Placebo IV, Single dose
干预措施: MTX-101 (Drug)
Cohort AS3 - Healthy Vounteers
(n = 6): MTX-101, Dose Level 3 IV or Placebo IV, single dose
干预措施: MTX-101 (Drug)
Cohort AS5 - Healthy Volunteers
(n = 6): MTX-101, Dose level 6 IV or Placebo IV, Single Dose
干预措施: MTX-101 (Drug)
Cohort AM1 - Healthy Volunteers
Cohort AM1 (n = 6): MTX-101, Dose Level 5 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses
干预措施: MTX-101 (Drug)
结局指标
主要结局
Safety of multiple, ascending dose levels of MTX-101
时间窗: Enrollment to 11 weeks following the last dose
Assess the safety of multiple, ascending dose levels of MTX-101by evaluating the incidence, severity, and seriousness of treatment-emergent adverse events
Safety of single, ascending dose levels of MTX-101
时间窗: Enrollment to 8 weeks post dose
Assess the safety of single, ascending dose levels of MTX-101 by evaluating the incidence, severity, and seriousness of treatment-emergent adverse events
次要结局
- anti-drug antibody (ADA) formation(Enrollment to 11 weeks following the last dose)
- pharmacokinetics (PK) of MTX-101(Enrollment to 11 weeks following the last dose)