NCT03375138已完成1 期
A Randomized, Open-label, Parallel-group, Single-dose, Biocomparability Study of the Pharmacokinetics of Belatacept Drug Products Using Active Pharmaceutical Ingredient Manufactured by Process E PPQ Relative to Active Pharmaceutical Ingredient Manufactured by Process C in Healthy Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2017年12月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).
研究概览
简要总结
This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed informed consent form.
- •Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
- •Weight between 60.0 to 100.0 kg, inclusive.
- •Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
- •WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.
- •Women must not be breastfeeding.
- •Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.
排除标准
- •Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
- •History of shingles (herpes zoster).
- •Personal or strong family history of cancer.
- •Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
- •Any known or suspected autoimmune disorder.
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Process E PPQ belatacept
Experimental
10 mg/kg, single dose by intravenous (IV) infusion.
干预措施: belatacept (Drug)
Process C belatacept
Experimental
10 mg/kg, single dose by intravenous (IV) infusion.
干预措施: belatacept (Drug)
结局指标
主要结局
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)).
时间窗: Up to day 57
Measured by plasma concentration.
Maximum observed serum concentration (Cmax).
时间窗: Up to day 57
Measured by plasma concentration.
次要结局
- Number of participants with electrocardiogram (ECG) abnormalities.(Up to 71 days.)
- Incidence of Adverse Events (AEs) leading to discontinuation.(Up to 71 days.)
- Number of participants with vital sign abnormalities.(Up to 71 days.)
- Incidence of non-serious Adverse Events (AEs).(Up to 71 days.)
- Incidence of Serious Adverse Events (SAEs).(Up to 71 days.)
- Number of participants with clinical laboratory abnormalities.(Up to 71 days.)
- Number of participants with physical examination abnormalities.(Up to 71 days.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different ProcessesRheumatoid ArthritisNCT03714022Bristol-Myers Squibb140
已完成
1 期
A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male SubjectsBioavailability StudyNCT03334084argenx40
已完成
1 期
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process CRenal TransplantationNCT02564497Bristol-Myers Squibb491
已完成
1 期
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy ParticipantsHealthy ParticipantsNCT05981976Bristol-Myers Squibb174
已完成
1 期
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency AnaemiaIron DeficiencyAnaemiaNCT06080555Sichuan Huiyu Pharmaceutical Co., Ltd84