A Randomised, Double-blind, Placebo-controlled, Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of MT-2990 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability as measured by vital signs
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and immunogenicity of MT-2990 in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects are able and willing to provide written informed consent to participate in this study
- •Healthy male subjects aged 18 to 55 years (inclusive)
- •Free from clinically significant (CS) illness or disease
- •Body weight of 60 to 100 kg (inclusive)
- •Body mass index (Quetelet index) ranging from 18 to 30 kg/m2 (inclusive).
排除标准
- •A CS endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological (including history of seizures), renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness or disorder (including anxiety, depression and reactive depression)
- •Presence or history of any known malignancy with the exception of basal cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 6 months prior to the Screening Visit
- •A history of bacterial or viral infections that led to hospitalisation and IV antibiotic or antiviral treatment within 3 months prior to Screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day -1
- •A history of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is two episodes within 6 months)
- •A history of tuberculosis (TB) or malaria; history or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal)
- •An active, or history of, parasitic infections; any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (e.g., history of splenectomy)
- •Presence or history of severe adverse reaction or allergy to any drug or allergy that is of clinical significance to the Investigational Medicinal Product (IMP)
- •A positive test result for QuantiFERON-TB Gold® Plus, hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.
研究组 & 干预措施
Dose 1
MT-2990 or Placebo
干预措施: MT-2990 (Drug)
Dose 1
MT-2990 or Placebo
干预措施: Placebo (Drug)
Dose 2
MT-2990 or Placebo
干预措施: MT-2990 (Drug)
Dose 2
MT-2990 or Placebo
干预措施: Placebo (Drug)
Dose 3
MT-2990 or Placebo
干预措施: MT-2990 (Drug)
Dose 3
MT-2990 or Placebo
干预措施: Placebo (Drug)
Dose 4
MT-2990 or Placebo
干预措施: MT-2990 (Drug)
Dose 4
MT-2990 or Placebo
干预措施: Placebo (Drug)
Dose 5
MT-2990 or Placebo
干预措施: MT-2990 (Drug)
Dose 5
MT-2990 or Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability as measured by vital signs
时间窗: Up to Day 85
Vital signs variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by ECG parameters
时间窗: Up to Day 85
12-lead ECG variables and changes from Baseline will be summarised by dose level.
Safety and tolerability as measured by physical examination
时间窗: Up to Day 85
Physical examination data will be listed by subject.
Safety and tolerability as measured by incidence, nature and severity of adverse events
时间窗: Up to Day 85
Adverse events will be summarised by dose level.
Safety and tolerability as measured by clinical laboratory assessments
时间窗: Up to Day 85
Laboratory variables and changes from Baseline will be summarised by dose level.
次要结局
- Mean residence time from time zero to infinity (MRT0-∞) of MT-2990(Up to Day 85)
- Proportion of subjects who develop antibodies against MT-2990 in serum(Up to Day 85)
- Maximum observed serum concentration (Cmax) of MT-2990(Up to Day 85)
- Apparent terminal elimination half-life (t1/2) of MT-2990(Up to Day 85)
- Terminal elimination rate constant (Kel) of MT-2990(Up to Day 85)
- Apparent volume of distribution at steady state (Vss) of MT-2990(Up to Day 85)
- Measured time of maximum observed serum concentration (tmax) of MT-2990(Up to Day 85)
- AUC from time zero to the last measurable concentration (AUC0-last) of MT-2990(Up to Day 85)
- AUC from time zero to infinity (AUC0-∞) of MT-2990(Up to Day 85)
- Apparent volume of distribution during terminal phase after IV administration (Vz) of MT-2990(Up to Day 85)
- Apparent serum clearance (CL) of MT-2990(Up to Day 85)
- Percentage of AUC obtained by extrapolation (%AUCex) of MT-2990(Up to Day 85)