NCT04920370已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
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
- 97
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs)
研究概览
简要总结
This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).
详细描述
Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.
The study will be conducted in healthy adult participants, including participants of Japanese descent.
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
- 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
- •Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
- •Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
- •Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
- •No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
- •For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.
排除标准
- •Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
- •History of complement deficiency or complement activity below the reference range.
- •Female participants who are breastfeeding.
- •Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
- •Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.
研究组 & 干预措施
ALXN1720 Single Dose SC + rHuPH20
Experimental
Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20.
干预措施: ALXN1720 SC (Drug)
ALXN1720 Single Dose SC
Experimental
Participants will receive a single dose of ALXN1720 SC.
干预措施: ALXN1720 SC (Drug)
ALXN1720 Multiple Dose SC
Experimental
Participants will receive multiple doses of ALXN1720 SC.
干预措施: ALXN1720 SC (Drug)
ALXN1720 Single Dose SC + rHuPH20
Experimental
Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20.
干预措施: rHuPH20 (Drug)
ALXN1720 Single Dose IV
Experimental
Participants will receive a single dose of ALXN1720 IV.
干预措施: ALXN1720 IV (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo SC or Placebo IV according to their assigned cohort.
干预措施: Placebo SC (Drug)
Placebo
Placebo Comparator
Participants will receive Placebo SC or Placebo IV according to their assigned cohort.
干预措施: Placebo IV (Drug)
结局指标
主要结局
Incidence of Treatment-emergent and Serious Adverse Events (TEAEs, SAEs)
时间窗: Up to 176 days following the first day of dosing
次要结局
- Maximum Observed Concentration (Cmax) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV(Up to 176 days following the first day of dosing)
- Area Under The Concentration-time Curve (AUC) of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV(Up to 176 days following the first day of dosing)
- Change from Baseline in Serum Concentrations of Free Complement Component 5 (C5)(Baseline, 176 days following the first day of dosing)
- Change from Baseline in Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity(Baseline, 176 days following the first day of dosing)
- Change from Baseline in Serum Concentrations of Total C5(Baseline, 176 days following the first day of dosing)
- Comparison of AUC of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
- Comparison of Change from Baseline in Serum Concentrations of Free C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Baseline, 176 days following the first day of dosing)
- Comparison of Change from Baseline in Serum Concentrations of Total C5 Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Baseline, 176 days following the first day of dosing)
- Incidence of Antidrug Antibodies (ADAs) to ALXN1720(Up to 176 days following the first day of dosing)
- Absolute Bioavailability of ALXN1720(Up to 176 days following the first day of dosing)
- Comparison of Incidence of TEAEs and SAEs Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
- Comparison of Cmax of ALXN1720 SC, ALXN1720 SC/rHuPH20, and ALXN1720 IV Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
- Comparison of Change from Baseline in Serum Concentrations in Ex Vivo cRBC Hemolysis Activity Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Baseline, 176 days following the first day of dosing)
- Comparison of ADAs to ALXN1720 Between Healthy Non-Japanese Participants and Participants of Japanese Descent(Up to 176 days following the first day of dosing)
研究者
研究点 (1)
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