A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of adverse events, graded by severity
研究概览
简要总结
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form (ICF)
- •Body mass index (BMI) between 18 and 32 kg/m2, inclusive
- •Weight 40-100 kg
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
- •Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening
- •Willing to abstain from using drugs of abuse while enrolled in the study
- •Willing and able to comply with protocol-specified criteria in regard to contraceptive protection
- •Able to comply with the study protocol, in the investigator's judgment
排除标准
- •History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
- •History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor
- •History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)
- •History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
- •History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening
- •Current tobacco smokers (positive history within 3 months before initiation of dosing on Day 1), or those with positive cotinine test at check-in
- •Positive drug screen at screening or at check-in
- •Positive pregnancy test result at screening or Day -1 or breast feeding during the study
- •Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe enrollment in and completion of the study
- •Unwillingness to comply or other conditions that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol
研究组 & 干预措施
Cohort A
干预措施: MHAB5553A (Drug)
Cohort A
干预措施: Matching placebo (Drug)
Cohort B
干预措施: MHAB5553A (Drug)
Cohort B
干预措施: Matching placebo (Drug)
Cohort C
干预措施: MHAB5553A (Drug)
Cohort C
干预措施: Matching placebo (Drug)
Cohort D
干预措施: MHAB5553A (Drug)
Cohort D
干预措施: Matching placebo (Drug)
Cohort E
干预措施: MHAB5553A (Drug)
Cohort E
干预措施: Matching placebo (Drug)
结局指标
主要结局
Incidence of adverse events, graded by severity
时间窗: Until study discontinuation/termination, up to 120 days
Changes in physical examination finding during and following MHAB5553A administration
时间窗: Throughout the study, up to 120 days
Changes in electrocardiogram (ECG) findings during and following MHAB5553A
时间窗: Throughout the study, up to 120 days
Incidence of serum anti-MHAB5553A antibodies
时间窗: Until study discontinuation/termination, up to 120 days
Changes in vital signs during and following MHAB5553A administration
时间窗: Throughout the study, up to 120 days
Changes in clinical laboratory results during and following MHAB5553A administration
时间窗: Throughout the study, up to 120 days
次要结局
- Clearance (CL) of MHAB5553A(Up to 120 days)
- Maximum serum concentration (Cmax) of MHAB5553A(Up to 120 days)
- Volume of distribution at steady-state (Vss) of MHAB5553A(Up to 120 days)
- Area under the concentration-time curve up to last measurable time point (AUC0-last) of MHAB5553A(Up to 120 days)
- Terminal elimination half-life (t1/2) of MHAB5553A(Up to 120 days)
- Mean Residence Time (MRT) of MHAB5553A(Up to 120 days)
- Time to Cmax (tmax) of MHAB5553A(Up to 120 days)
- Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MHAB5553A(Up to 120 days)