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
- 48
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
详细描述
This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.
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 55 Years（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 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
- •Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.
排除标准
- •Current/recurrent diseases or relevant medical history.
- •Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
- •Participants who have prior exposure to ALXN
- •Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
- •Participants with hepatitis B or C, or human immunodeficiency virus.
- •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: ALXN1830 Single Dose 1/Placebo
Participants will receive a single SC dose of ALXN1830 or placebo.
干预措施: ALXN1830 (Drug)
Cohort 1: ALXN1830 Single Dose 1/Placebo
Participants will receive a single SC dose of ALXN1830 or placebo.
干预措施: Placebo (Drug)
Cohort 2: ALXN1830 Single Dose 2/Placebo
Participants will receive a single SC dose of ALXN1830 or placebo.
干预措施: ALXN1830 (Drug)
Cohort 2: ALXN1830 Single Dose 2/Placebo
Participants will receive a single SC dose of ALXN1830 or placebo.
干预措施: Placebo (Drug)
Cohort 3: ALXN1830 Multiple Dose 1/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
干预措施: ALXN1830 (Drug)
Cohort 3: ALXN1830 Multiple Dose 1/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
干预措施: Placebo (Drug)
Cohort 4: ALXN1830 Multiple Dose 2/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
干预措施: ALXN1830 (Drug)
Cohort 4: ALXN1830 Multiple Dose 2/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
干预措施: Placebo (Drug)
Cohort 5: ALXN1830 Multiple Dose 3/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
干预措施: ALXN1830 (Drug)
Cohort 5: ALXN1830 Multiple Dose 3/Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo.
干预措施: Placebo (Drug)
Cohort 6: ALXN1830 /Placebo in Japanese Population
Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.
干预措施: ALXN1830 (Drug)
Cohort 6: ALXN1830 /Placebo in Japanese Population
Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.
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: Day 1 (postdose) through follow-up (up to approximately 141 days)
An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
次要结局
- Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830(Day 1 (predose) up to Day 64 (postdose))
- Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1(Day 1 (predose up to 12 hours postdose))
- Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22(Day 22 (predose up to 12 hours postdose))
- Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78(Day 78 (predose up to 12 hours postdose))
- Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)(Baseline, early termination visit (up to Day 141))
- Percent FcRN Receptor Occupancy at Day 120(Day 120)
- Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830(Day 1 (postdose) through follow-up (up to approximately 141 days))