NCT05602025已完成1 期
An Open-Label, Randomized, Single-Dose, Multicenter, Parallel-Group Study to Compare the Pharmacokinetics of Subcutaneous Depemokimab When Delivered With a Safety Syringe Device or an Autoinjector in Healthy Adult Participants
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Maximum observed plasma concentration (Cmax) of depemokimab
研究概览
简要总结
This study will compare the pharmacokinetics, safety, tolerability, and immunogenicity of Depemokimab administered via a SSD or autoinjector in healthy participants.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
- •Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
- •Women who have the potential to become pregnant must use a form of highly-effective contraception.
- •Capable of giving signed informed consent.
排除标准
- •History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- •Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/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.
- •Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening.
- •Recent prior or concurrent clinical study experience.
研究组 & 干预措施
Depemokimab via SSD
Experimental
Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1.
干预措施: Depemokimab (Biological)
Depemokimab via autoinjector
Experimental
Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1.
干预措施: Depemokimab (Biological)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of depemokimab
时间窗: Up to Week 26
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab
时间窗: Up to Week 26
Maximum Observed Plasma Concentration (Cmax) of Depemokimab
时间窗: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab
时间窗: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods.
次要结局
- Area under the concentration time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab(Up to week 26)
- Apparent clearance following extravascular administration (CL/F) of depemokimab(Up to Week 26)
- Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab(Up to week 26)
- Terminal elimination half life (T1/2) of depemokimab(Up to Week 26)
- Number of participants with presence of anti-drug antibody and neutralizing antibody to depemokimab(Pre-dose and Weeks 4, 8, 12, 26 post dose)
- Time to maximum observed plasma concentration (Tmax) of depemokimab(Up to Week 26)
- Terminal elimination rate constant (lambda z) of depemokimab(Up to Week 26)
- Percentage of AUC(0-inf) due to extrapolation from Tlast to infinity (%AUCex) of depemokimab(Up to Week 26)
- Time of last measurable plasma concentrations (Tlast) of depemokimab(Up to week 26)
- Area Under the Concentration-time Curve From Time Zero to Time of Last Observed Quantifiable Concentration (AUC[0-t]) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Time to Maximum Observed Plasma Concentration (Tmax) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Apparent Clearance Following Extravascular Administration (CL/F) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Apparent Volume of Distribution Following Extravascular Administration (Vd/F) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Terminal Elimination Rate Constant (Lambda z) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Terminal Elimination Half-Life (T1/2) Following Administration of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Time of Last Measurable Plasma Concentrations (Tlast) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Percentage of AUC (0-Inf) Due to Extrapolation From the Time of the Last Observed Concentration (Tlast) to Infinity (%AUCex) of Depemokimab(Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose)
- Number of Participants With Presence of Positive Anti-depemokimab Antibodies(Baseline (Day 1), Weeks 4, 8, 12 and 26)
- Number of Participants With Positive Neutralizing Antibodies to Depemokimab(Baseline (Day 1), Weeks 4, 8, 12 and 26)
研究者
研究点 (4)
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