A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study Comparing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of Rozanolixizumab in Japanese, Chinese and Caucasian Healthy-Volunteer Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants
研究概览
简要总结
The purpose of the study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of rozanolixizumab in japanese, chinese and caucasian healthy-volunteer study participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Study participant must be 18 to 65 years of age, inclusive, at the time of signing the Informed Consent form (ICF)
- •Study participants who are overtly healthy in the opinion of the investigator as determined by medical history and a general clinical examination, including physical examination, laboratory tests, and cardiac monitoring
- •Study participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the investigator, and is able to communicate satisfactorily with the investigator and comply with all clinical study requirements
- •Japanese or Chinese study participant is of Japanese or Chinese descent, determined by verbal confirmation of familial heritage with all 4 grandparents of Japanese or Chinese descent
- •Caucasian study participant is of Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents of Caucasian descent
- •Study participant is of normal weight as determined by a body mass index (BMI) between 18 and 32 kg/m2, inclusive, with a body weight of at least 50 kg (male) or 45 kg (female) and no greater than 100 kg
排除标准
- •Any medical (acute or chronic illness) or psychiatric condition that, in the opinion of the investigator, could harm the study participant or would compromise the study participant's ability to participate in this study.
- •History of known inflammatory bowel disease, active diverticular disease, or a history of confirmed duodenal, gastric, or esophageal ulceration in the previous 6 months
- •Significant allergies to humanized monoclonal antibodies
- •Known hypersensitivity to any components of the investigational medicinal product (IMP)
- •Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
- •Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- •Study participant is splenectomized, or has a clinically relevant active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to study treatment
- •Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- •Received a vaccination within 8 weeks prior to Day -1; or intends to have a vaccination during the course of the study. Prior/Concurrent clinical study experience
- •Exposure to more than 3 new chemical entities within 12 months prior to dosing
- •Previously participated in this clinical study or has previously been assigned to treatment in a clinical study of IMP under investigation in this clinical study
- •Participated in another study of an IMP (or a medical device) within the previous 90 days or 5 half-lives prior to Day -1 (whichever is longer) or is currently participating in another study of an IMP (or a medical device)
研究组 & 干预措施
Dose 1 of rozanolixizumab in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 2 of rozanolixizumab in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 1 of rozanolixizumab in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 2 of rozanolixizumab in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 3 of rozanolixizumab in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 3 of rozanolixizumab in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 2 of rozanolixizumab in Chinese subjects
Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Dose 3 of rozanolixizumab in Chinese subjects
Chinese subjects will be randomized to receive a predefined dosage of rozanolixizumab in order to maintain the blinding.
干预措施: Rozanolixizumab (Drug)
Placebo in Japanese subjects
Japanese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.
干预措施: Placebo (Drug)
Placebo in Chinese subjects
Chinese subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.
干预措施: Placebo (Drug)
Placebo in Caucasian subjects
Caucasian subjects will be randomized to receive a predefined dosage of placebo in order to maintain the blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Japanese study participants
时间窗: From Baseline until Safety Follow-up (up to Week 8)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Japanese study participants
时间窗: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time of observed Cmax (tmax)
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Chinese study participants
时间窗: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration
Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Chinese study participants
时间窗: From Baseline until Safety Follow-up (up to Week 8)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Japanese study participants
时间窗: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax) of rozanolixizumab in healthy Chinese study participants
时间窗: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Maximum observed plasma concentration (Cmax)
Time to maximum observed plasma concentration (tmax) of rozanolixizumab in healthy Chinese study participants
时间窗: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
Time of observed Cmax (tmax)
Area under the concentration-time curve from time 0 to time t (AUC(0-t)) of rozanolixizumab in healthy Japanese study participants
时间窗: Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours
AUC(0-t): Area under the curve from time 0 to time t, the time of last quantifiable concentration
次要结局
- Treatment-emergent adverse events (TEAEs) from Baseline to Safety Follow-up (SFU) in healthy Caucasian(From Baseline until Safety Follow-up (up to Week 8))
- AUC(0-t)/D: Dose normalized AUC(0-t)(Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours)
- AUC(0-t)/BW: Body weight normalized AUC(0-t) of rozanolixizumab(Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours)
- AUC(0-t)/D/BW: Dose and body weight normalized AUC(0-t)(Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours)
- Cmax/BW: Body weight normalized Cmax of rozanolixizumab(Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours)
- Cmax/D: Dose normalized Cmax(Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours)
- Cmax/D/BW: Dose and body weight normalized Cmax(Sampling time points for plasma Pharmacokinetics will be as follows: predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144 and 216 hours)