An Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Two Dose Levels of GSK3511294 Administered Subcutaneously in Chinese Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294
研究概览
简要总结
This single dose pharmacokinetic (PK) study aims to investigate the PK, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant between 18 to 45 years of age.
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs.
- •Body weight greater than or equal to (>=)50.0 kilograms (kg) for males, >=45.0 kg for females, and body mass index (BMI) within the range (19.0-26.0) kg/meter square (m^2) (inclusive).
- •Contraceptive use by men and/or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent.
排除标准
- •Participant is pregnant, breastfeeding, or a woman of childbearing potential
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- •Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe allergic reactions/intolerance
- •Current evidence or recent history of an infective illness
- •A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
- •Clinically significant abnormalities
- •Participants with Coronavirus Disease-2019 (COVID-19)
- •With prior/concurrent clinical study experience.
结局指标
主要结局
AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294
时间窗: Up to Week 4
AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294
时间窗: Up to Week 12
Time to last quantifiable concentration (tlast) of GSK3511294
时间窗: Up to Week 26
Apparent clearance (CL/F) of GSK3511294
时间窗: Up to Week 26
Apparent volume of distribution (Vz/F) of GSK3511294
时间窗: Up to Week 26
Area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of GSK3511294
时间窗: Up to Week 26
AUC from time 0 (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC[0-t]) of GSK3511294
时间窗: Up to Week 26
AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294
时间窗: Up to Week 26
Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294
时间窗: Up to Week 26
Time of occurrence of Cmax (tmax) of GSK3511294
时间窗: Up to Week 26
Maximum observed plasma concentration (Cmax) of GSK3511294
时间窗: Up to Week 26
Terminal elimination rate constant (lambda z) of GSK3511294
时间窗: Up to Week 26
Terminal phase half-life (t1/2) of GSK3511294
时间窗: Up to Week 26
次要结局
- Change from Baseline in Hemoglobin (Grams per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in mean Corpuscular Hemoglobin (Picograms)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) (Milliseconds [msec])(Baseline (Pre-dose on Day 1) and up to Week 26)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Week 30)
- Change from Baseline in hematocrit (Proportion of RBC in blood)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in mean corpuscular volume (Femtoliters)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Ratio to Baseline of C3 and C4(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in body temperature (Degrees Celsius)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes and neutrophils (10^9 cells per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in Red blood cell (RBC) count (10^12 cells per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in percentage of Reticulocytes (Percentage of reticulocytes)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in Sodium, potassium, calcium, Blood urea nitrogen (Millimoles per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in Albumin, Total Protein (Grams per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in systolic and diastolic blood pressure (Millimeters of Mercury)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Number of participants with positive Anti-drug Antibodies (ADAs) against GSK3511294(Up to Week 26)
- Change from Baseline in Creatinine, total bilirubin, direct bilirubin (Micromoles per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Change from Baseline in Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) (International units per liter)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Absolute values of Complement (C) 3 and C4(Up to Week 26)
- Change from Baseline in pulse rate (Beats per minute)(Baseline (Pre-dose on Day 1) and up to Week 26)
- Titers of ADA against GSK3511294(Up to Week 26)