A Phase 1, First-In-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CND319 in Healthy Participants and Patients With Rheumatic Diseases
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Changes from baseline in ECG parameters through end of study: QRS interval
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.
详细描述
This is a Phase 1, first-in-human, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy participants and patients with rheumatic diseases. The study consists of two parts: a dose escalation part and an open-label expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 to 65 years old
- •Body mass index 18-30 kg/m2 and weight 55-100 kg
- •Individuals in good health
- •Agree to abstain from consumption of alcohol 48 hours prior to study visits
- •Agree to the use of highly effective contraception as defined in the protocol
- •Inclusion Criteria (MAD and Part 2 Expansion):
- •Patients with RA:
- •18 to 75 years old
- •Diagnosis of adult-onset RA
- •Class I-III RA
- •Moderately to severely active RA
- •Patients with SjD:
- •18 to 75 years old
- •Diagnosis of primary SjD
排除标准
- •Inadequate clinical laboratory parameters at Screening
- •Active infection
- •Receipt of or inability to discontinue any excluded therapies
- •Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons
- •History of alcohol or drug abuse within last 12 months
- •Positive alcohol breathalyzer or drug screen prior to dosing
- •Inability to comply with protocol-mandated requirements
- •History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug
- •Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study
- •Blood donation or significant blood loss within 30 days
- •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
- •Exclusion Criteria for patients with RA or SjD:
- •Inadequate clinical laboratory parameters at Screening
- •Active infection
- •Receipt of or inability to discontinue any excluded therapies
- •History of progressive multifocal leukoencephalopathy
- •Central nervous system disease
- •Presence of 1 or more significant concurrent medical conditions
- •Have a diagnosis or history of malignant disease within 5 years
- •History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug
- •Women who are pregnant or breastfeeding
- •Patients who do not agree to the use of highly effective contraception as defined by the protocol
研究组 & 干预措施
CND319
CND319 will be dosed according to the assigned cohort
干预措施: CND319 (Biological)
结局指标
主要结局
Changes from baseline in ECG parameters through end of study: QRS interval
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: QT interval
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Incidence proportion and severity of treatment-emergent adverse events through end of study
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to body temperature
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
oral, tympanic, or axillary
Changes to heart rate
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to respiratory rate
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes to blood pressure
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
systolic and diastolic
Changes to pulse oximetry
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in ECG parameters through end of study: PR interval
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
Changes from baseline in safety laboratory assessments through end of study
时间窗: Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2)
次要结局
- PK parameters for CND319: Maximum observed concentration (Cmax)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- PK parameters for CND319: Time to maximum observed concentration (Tmax)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- PK parameters for CND319: Area under the concentration-time curve (AUC)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- PK parameters for CND319: Apparent clearance (CL/F)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- PK parameters for CND319: Apparent volume of distribution (Vz/F)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- PK parameters for CND319: Terminal elimination half-life (t1/2)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- Frequency of participants/patients with anti-drug antibodies (ADAs)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))
- Percentage of participants/patients with anti-drug antibodies (ADAs)(Baseline through Week 12 (SAD) or Week 24 (MAD/Part 2))