NCT07236411已完成1 期
A Randomized, Double-blind, Phase 1 Study to Evaluate the Absolute Bioavailability of Cizutamig Following Single Intravenous or Subcutaneous Administration in Healthy Adult Participants
Candid Therapeutics2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年12月4日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Absolute bioavailability
研究概览
简要总结
The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.
详细描述
This is a randomized, double-blind, Phase 1 study designed to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants. The study will enroll participants in SC and IV cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18-65 years of age
- •Body mass index 18-30 kg/m2 and weight 55-100 kg
- •Individuals in good health
- •Meets vaccination requirements as defined by the protocol
- •Agree to abstain from consumption of alcohol within 48-hrs of study visits
- •Agree to the use of highly effective contraception as defined by the protocol
排除标准
- •Active Infection
- •Inadequate clinical laboratory parameters at Screening
- •Receipt of or inability to discontinue any excluded therapies
- •Individuals who will decline blood products
- •Individuals with immediate household contacts with young children (eg, ≤ 6 years old) or immunocompromised persons
- •History of drug or alcohol abuse within last 12 months
- •Individuals who are hypersensitive to intravenous immunoglobulin (IVIg)
- •History of severe allergic or anaphylactic reactions to mAb therapy (or recombination antibody-related fusion proteins) or any constituents of study drug
- •Major surgery requiring the use of general anesthesia within 12 weeks prior to Screening or planned or expected major surgery during the study period (from Screening to the individual's last visit)
- •Blood donation or significant blood loss within 30 days prior to screening
- •Individuals considered to be part of a vulnerable population (eg, incarceration)
- •Individuals that in the opinion of the Investigator, are not suitable for participation in the trial
- •Inability to comply with protocol-mandated requirements
研究组 & 干预措施
IV infusion of cizutamig
Experimental
IV cizutamig
干预措施: cizutamig (Biological)
SC injection of cizutamig
Experimental
cizutamig subcutaneous injection
干预措施: cizutamig (Biological)
SC injection of placebo
Placebo Comparator
placebo subcutaneous injection
干预措施: Placebo (Other)
IV infusion of placebo
Placebo Comparator
IV placebo
干预措施: Placebo (Other)
结局指标
主要结局
Absolute bioavailability
时间窗: Baseline to 8 weeks
次要结局
- Changes in heart rate(Baseline to 8 weeks)
- PK parameter for cizutamig: t½(Baseline to 8 weeks)
- PK Parameters for cizutamig: CL(Baseline to 8 Weeks)
- Changes in body temperature(Baseline to 8 Weeks)
- Changes in ECG parameters from baseline through end of study: RR(Baseline to 8 Weeks)
- Changes from baseline in safety laboratory assessments through end of study: serum chemistry(Baseline to 8 Weeks)
- Incidence and severity of treatment-emergent adverse events through end of study(Baseline to 8 weeks)
- Changes in body temperature(Baseline to 8 Weeks)
- Changes in ECG parameters from baseline through end of study: QTcF(Baseline to 8 Weeks)
- Changes from baseline in safety laboratory assessments through end of study: serum chemistry(Baseline to 8 Weeks)
- Changes in blood pressure(Baseline to 8 weeks)
- PK parameters for cizutamig: AUC and dose-normalized AUC(Baseline to 8 weeks)
- PK parameter for cizutamig: t½(Baseline to 8 weeks)
- PK Parameters for cizutamig: CL(Baseline to 8 Weeks)
- Changes in ECG parameters from baseline through end of study: PR interval(Baseline to 8 Weeks)
- Changes in ECG parameters from baseline through end of study: RR(Baseline to 8 Weeks)
- PK Parameters for cizutamig: Vz/F(Baseline to 8 Weeks)
- Changes in ECG parameters from baseline through end of study: QTcB(Baseline to 8 Weeks)
- PK parameters for cizutamig: Cmax and dose-normalized Cmax(Baseline to 8 Weeks)
- PK Parameters for cizutamig: CL/F(Baseline to 8 weeks)
- Changes in respiratory rate(Baseline to 8 weeks)
- Changes in pulse oximetry(Baseline to 8 weeks)
- Changes in ECG parameters from baseline through end of study: QT interval(Baseline to 8 Weeks)
- PK Parameters for cizutamig: Vz(Baseline to 8 weeks)
- PK parameter for cizutamig: Tmax(Baseline to 8 Weeks)
- Changes in ECG parameters from baseline through end of study: QRS interval(Baseline to 8 Weeks)
- PK Parameters for cizutamig: Vss(Baseline to 8 weeks)
- Changes in heart rate(Baseline to 8 weeks)
- Changes from baseline in Red Blood Cell count(Baseline to 8 weeks)
- Anti-drug antibodies (ADAs)(Baseline to 8 weeks)
- Changes from baseline in White Blood Cell count(Baseline to 8 weeks)
- Changes from baseline in Platelets(Baseline to 8 weeks)
- Changes from baseline in Hematocrit(Baseline to 8 weeks)
- Changes from baseline in Hemoglobin(Baseline to 8 weeks)
研究者
研究点 (2)
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