A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.
详细描述
This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •Satisfactory medical assessment.
- •Participants must have had vaccination against pneumococcus (Pneumovax 23 [PPSV23]) at least 28 days, and maximally 4 years prior to Day
- •Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day
- •Body weight within 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m^2, inclusive.
- •Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.
排除标准
- •Current/recurrent diseases or relevant medical history.
- •Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
- •Participants who have prior exposure to ALXN
- •Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
- •Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
- •Presence of hepatitis B surface antigen (HBsAg) at Screening.
- •Positive hepatitis C antibody test result at Screening.
- •Positive human immunodeficiency virus (HIV) antibody test at Screening.
- •Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies
研究组 & 干预措施
Cohort 1
Participants will receive a single SC dose of ALXN1830 or placebo (750 mg).
干预措施: ALXN1830 (Drug)
Cohort 1
Participants will receive a single SC dose of ALXN1830 or placebo (750 mg).
干预措施: Placebo (Drug)
Cohort 2
Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg).
干预措施: ALXN1830 (Drug)
Cohort 2
Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg).
干预措施: Placebo (Drug)
Cohort 3
Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg).
干预措施: ALXN1830 (Drug)
Cohort 3
Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg).
干预措施: Placebo (Drug)
Cohort 4
Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total).
干预措施: ALXN1830 (Drug)
Cohort 4
Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total).
干预措施: Placebo (Drug)
Cohort 5
Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total).
干预措施: ALXN1830 (Drug)
Cohort 5
Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total).
干预措施: Placebo (Drug)
Cohort 6
Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total).
干预措施: ALXN1830 (Drug)
Cohort 6
Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total).
干预措施: Placebo (Drug)
Cohort 7
Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total).
干预措施: ALXN1830 (Drug)
Cohort 7
Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total).
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline up to Day 64
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
次要结局
- Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10(Baseline, Day 10)
- Number of Participants With Positive Anti-Drug Antibodies (ADA)(Baseline up to Day 64)
- Number of Participants With Positive Neutralizing Antibodies (NAbs)(Baseline up to Day 64)
- Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830(Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8)