A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of subjects with localized administration site AEs overall, by causality, and by severity
研究概览
简要总结
This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adult subjects aged ≥ 18 to ≤ 55 years
- •Females must be either postmenopausal or sterile
- •Body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤ 30 kg/m2
排除标准
- •History or current evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis, or history of liver disease, drug reaction, or aminotransaminase elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic (including history of migraine); psychiatric; immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer [except melanoma] who have had no evidence of disease in the last 5 years are eligible), that precludes designation of healthy subjects as judged by the Investigator
- •History or evidence of congenital or acquired immunosuppressive condition(s), including positive serology for human immunodeficiency virus infection or taking immunosuppressive agents.
- •Evidence of active or latent tuberculosis
- •Hospitalization within 3 months before IP administration or planned hospitalization at any time during the study.
- •History of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to latex or any drug product
- •A positive test result for drugs of abuse.
- •Smokers within 3 months before Screening.
研究组 & 干预措施
CSL730 (dose 1 with premedication)
administered as a single dose by subcutaneous (SC) injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 2 with premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 3 with premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 1 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 2 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 3 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 4 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 5 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 6 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
CSL730 (dose 7 without premedication)
administered as a single dose by SC injection or by SC infusion
干预措施: CSL730 (Biological)
Placebo
A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with localized administration site AEs overall, by causality, and by severity
时间窗: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with localized administration site AEs overall, by causality, and by severity
时间窗: Within 96 hours and up to 56 days after CSL730 administration
Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
时间窗: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with TEAEs overall, by causality, and by severity
时间窗: Within 96 hours and up to 56 days after CSL730 administration
次要结局
- Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples(up to 56 days after CSL730 administration)
- Terminal elimination half-life (T1/2) for CSL730 in serum samples(up to 56 days after CSL730 administration)
- Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples(up to 56 days after CSL730 administration)
- Maximum concentration (Cmax) for CSL730 in serum samples(up to 56 days after CSL730 administration)
- Apparent total systemic clearance (CL/F) for CSL730 in serum samples(up to 56 days after CSL730 administration)
- Levels of anti-CSL730 antibodies detected in serum samples(Days 15, 29, and 56)
- Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples(up to 56 days after CSL730 administration)
- Time of maximum concentration (Tmax) for CSL730 in serum samples(up to 56 days after CSL730 administration)