NCT04971395已完成1 期
A Randomized, Double-blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Participant With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human, single intravenous (IV) infusion of XTMAB-16 (formerly referred to as KBMAB-16) in normal healthy male and female participants.
详细描述
A total of 24 normal healthy adult participants will be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo) in each cohort. Participants will receive a single IV infusion of 2 mg/kg or 4 mg/kg of XTMAB-16 or placebo on Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant is a healthy adult male or female aged 18 to 45 years, inclusive, at the time of informed consent.
- •The participant weighs between 45 kg (99 lbs) and 100 kg (220 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at the time of informed consent.
- •The participant agrees to use highly effective method of contraception from the time of signing consent throughout 90 days after dosing.
排除标准
- •The participant has received any investigational compound within 90 days before dosing.
- •The participant has any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease or disorder, or other abnormality, which may affect the participant's safety, increase risk of seizure or lower the seizure threshold, or potentially confound the study results. It is the responsibility of the Investigator to assess the clinical significance of any conditions the participant may have; however, consultation with the Xentria Medical Monitor may be warranted.
- •The participant has a known hypersensitivity to any component of the formulation of XTMAB-
- •The participant has a positive result for drugs of abuse (defined as any illicit drug use) or alcohol at Screening or Baseline (Day -2).
- •The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening or is unwilling to agree to abstain from alcohol and drugs throughout the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Single IV Infusion
干预措施: Placebo (Drug)
XTMAB-16 2mg/kg
Experimental
Single IV Infusion
干预措施: XTMAB-16 2 mg/kg (Drug)
XTMAB-16 4mg/kg
Experimental
Single IV Infusion
干预措施: XTMAB-16 4mg/kg (Drug)
结局指标
主要结局
Participant With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to day 71
Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
次要结局
- XTMAB-16 Maximum Observed Concentration (Cmax)(Up to day 71)
- Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71(Up to day 71)
- Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞)(PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71)
- Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)(ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71)
- Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)(ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71)
- XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1(Day 1)
- Time to Maximum Observed Concentration (Tmax) XTMAB-16(PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71)
- Systemic Clearance After IV Dosing (CL)(Up to day 71)
- Mean Residence Time (MRT)(Up to day 71)
- Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)(PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71)
- Apparent Terminal Half-life (t1/2)(Up to day 71)
研究者
研究点 (1)
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