Relative Bioavailability of 40 mg/0.4 mL of BI 695501 Compared to 40 mg/0.8 mL of BI 695501 Formulation Following Single Subcutaneous Administration in Healthy Male and Female Subjects (a Double Blind, Randomised, Single-dose, Parallel-arm Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Maximum Measured Concentration of BI 695501 in Plasma (Cmax)
研究概览
简要总结
The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- •Age of 18 to 55 years (inclusive).
- •Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
- •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- •Participants of reproductive potential (childbearing potential1) must be willing and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year from at least 30 days before administration of the trial medication until 30 days after trial completion.
排除标准
- •Previous exposure to adalimumab or proposed adalimumab biosimilar drugs.
- •Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) that deviates from normal and judged as clinically relevant by the investigator.
- •Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
- •History of relevant orthostatic hypotension, fainting spells, or blackouts.
- •Chronic or relevant acute infections.
- •Positive result for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C (Hep C) at screening.
- •History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).
- •Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.
- •Further exclusion criteria apply.
研究组 & 干预措施
BI 695501 40 mg/0.4 mL (T)
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
干预措施: BI 695501 - higher concentration (Drug)
BI 695501 40 mg/0.8 mL (R)
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
干预措施: BI 695501 - lower concentration (Drug)
结局指标
主要结局
Maximum Measured Concentration of BI 695501 in Plasma (Cmax)
时间窗: BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration.
Maximum measured concentration of BI 695501 in plasma (Cmax). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1344 Hours After Dose Administration (AUC0-1344)
时间窗: BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration.
Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 to 1344 hours after dose administration (AUC0-1344). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
时间窗: BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration.
Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.
次要结局
未报告次要终点