A Double-Blind, Randomized, Placebo-Controlled, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Intravenous Doses of CM-101 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetic (PK) parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)
研究概览
简要总结
The study is designed to investigate the safety and tolerability of CM-101 for the treatment of medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
详细描述
A total of 32 male subjects were enrolled into the study and randomized to 4 treatment groups. The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42 days and an end of study (EOS) FU visit. In each Dose Group subjects was randomized to receive a single IV infusion of CM-101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Evidence or history of clinically relevant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies,). This includes any acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or CM-101 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- •History or current drug/alcohol abuse. History of regular alcohol consumption exceeding - 14 drinks/week for men (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening.
- •Hypereosinophilia defined as peripheral blood Eosinophils > 4.5×108/L (450/μl) or exceeding 7% of the circulating leukocytes.
- •Positive urine drug of abuse (DoA) in screening and on admission.
- •Positive breath alcohol test on admission.
- •Known acute or chronic allergy to any drug or hypersensitivity to any of the test compounds or contraindication to test product.
- •Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- •Having received any biological treatment with recombinant antibodies, immunological therapy, or anticancer treatment. Previous standard vaccination treatment is allowed.
- •Positive HIV, hepatitis HBsAg or hepatitis HCV Ab serology tests at Screening.
- •Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration.
- •Participation in another clinical trial within 3 months prior to dosing (calculated from the previous study's last dosing day).
- •Subjects with any acute medical situation (e.g. acute infection) within 48 hours of dosing, which is considered of significance by the Principal Investigator
- •Subjects with an inability to communicate well with the investigators and CRC staff (e.g., language problem, poor mental development).
研究组 & 干预措施
Anti-human CCL24 monoclonal antibody (CM-101)
Anti-human CCL24 monoclonal antibody (CM-101) Four (4) treatment groups (0.75 mg/kg, 2.5 mg/kg, 5.0 mg/kg, 10 mg/kg)
干预措施: Anti-human CCL24 monoclonal antibody (CM-101) (Drug)
Placebo
Placebo - intravenous infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma Pharmacokinetic (PK) parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)
时间窗: 1 day single-dose administration over 10 weeks
Observed maximum plasma concentration
Plasma Pharmacokinetic (PK) parameters of CM-101 - Time to Cmax (tmax)
时间窗: 1 day single-dose administration over 10 weeks
Time to reach the observed maximum plasma concentration (Tmax)
Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.
时间窗: 1 day single-dose administration over 10 weeks
Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination rate constant (λz)
时间窗: 1 day single-dose administration over 10 week
Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination half-life (T½)
时间窗: 1 day single-dose administration over 10 week
Terminal elimination half-life, defined as 0.693/λz
Plasma Pharmacokinetic (PK) parameters of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
时间窗: 1 day single-dose administration over 10 week
Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
次要结局
- Level of antibodies against CM-101(1 day single-dose administration over 10 week)
- Assessment, based on the safety profile(1 day single-dose administration over 10 week)