A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CD24Fc When Administered Intravenously in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead Electrocardiograms (ECGs), and Telemetry Monitoring
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses of efprezimod alfa in healthy adult participants.
详细描述
This was a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of efprezimod alfa in healthy male and female adult participants.
The population for this study was healthy males and females between the ages of 18 and 55 years, inclusive, with a body mass index between 18 kg/m^2 and 30 kg/m^2, inclusive.
A total of 40 participants were enrolled in this study, in 5 cohorts of 8 participants each. Six of the 8 participants in each cohort received study drug and 2 participants received placebo (0.9% sodium chloride, saline). The first cohort was dosed with 10 mg. Succeeding cohorts received 30 mg, 60 mg, 120 mg, and 240 mg of efprezimod alfa or matching placebo and were dosed at least 3 weeks apart to allow for review of safety and tolerability data for each prior cohort. Administration of the next higher dose to a new cohort of participants was permitted only if adequate safety and tolerability had been demonstrated.
In each cohort, the initial 2 participants were 1 study drug recipient and 1 placebo recipient on Day 1 (sentinel participants). Participants 3 to 5 and 6 to 8 were dosed after Day 7 (a minimum of 24 hours apart between the subgroups). Each participant was dosed at least 1 hour apart in the same subgroup. If necessary, dosing of the rest of the participants was delayed pending review of any significant safety issues that may have arisen during the post-dose period involving the first or second subgroups in that cohort. The subsequent cohort was dosed at least 3 weeks after the prior cohort.
The total study duration for each participant, including the screening period, was up to 63 days. Single dose administration occurred on Day 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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 and female volunteers between the ages of 18 and 55 years, inclusive, in good health based on medical history, physical examination, electrocardiogram (ECG), and routine laboratory tests (blood chemistry, hematology, urinalysis, and drug screen). Any routine laboratory test could be repeated per Investigator judgment;
- •Body mass index (BMI) between 18 kg/m2 and 30 kg/m2, inclusive;
- •Participants must have been non-smokers or had quit smoking >6 months prior to Screening;
- •Women of childbearing potential with a negative urine pregnancy test at Screening who were not breastfeeding, did not plan to become pregnant during the study, and agreed to use dual methods of birth control during the study (i.e., 2 of the following: diaphragm or cervical cap with spermicide, intrauterine device [IUD] hormonal contraceptives [stable for at least 3 months prior to Screening], male partner using condom with spermicide) from Day 1 until 60 days following the administration of study drug; or female participants of non-childbearing potential were either surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or >1 year post-menopausal with a follicle-stimulating hormone (FSH) in the post menopausal range (post-menopausal taking hormone replacement therapy [stable for at least 3 months prior to Screening] did not require an FSH level);
- •All male participants were required to use barrier contraception (condom with spermicide) in addition to having their female partner (if of childbearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, hormonal contraceptives [stable for at least 3 months prior to Screening]) from Day 1 until 60 days following the last administration of study drug;
- •Negative alcohol, cotinine, and drug screen;
- •Willing to abstain from alcohol for 48 hours prior to any visit;
- •Willing and able to be confined to the CPU as required by the protocol;
- •Willing and able to comply with the investigational nature of the study and able to communicate well with the Principal Investigator and clinical staff; and
- •Ability to comprehend and willingness to provide written informed consent in accordance with institutional and regulatory guidelines.
排除标准
- •Participants with evidence or history of clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies), surgical conditions, cancer or any other condition that, in the Investigator's opinion, might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug;
- •Participants who had received any investigational drug or device within 30 days or less than 5 half-lives of investigational drug prior to dosing;
- •Participants taking any prescription or over-the-counter medications within 7 days prior to dosing, or were not willing to refrain from these medications throughout the study period;
- •Participants who had a history of alcoholism or drug abuse within 2 years prior to dosing;
- •Participants with a typical consumption of 14 alcoholic drinks weekly;
- •Participants who had a history of or positive tests for human immunodeficiency virus (HIV) or hepatitis C virus (HCV), or participants who had a positive hepatitis B surface antigen (HBsAg) at Screening;
- •Participants who had donated blood or blood products within 30 days prior to dosing;
- •Participants with inadequate venous access;
- •Participants with an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 the upper limit of normal (ULN) at Screening or Day -1;
- •Participants with a total bilirubin >1.5 ULN at Screening or Day -1;
- •Participants who were currently undergoing treatment with weight loss medication or prior weight loss surgery (e.g., gastric bypass surgery);
- •Participants who had poor mental function or any other reason to expect participant difficulty in complying with the requirements of the study; or
- •Participants who had a history or presence of any medical condition or disease that, in the opinion of the Investigator, could interfere with the conduct of the study or would put the participant at unacceptable risk.
研究组 & 干预措施
Efprezimod alfa
Single dose of efprezimod alfa is administrated as intravenous infusion in one hour. There are 5 dose cohorts, 10mg, 30mg, 60mg, 120mg, 240mg. Each cohort has 6 subjects in efprezimod alfa and 2 subject in placebo.
干预措施: Efprezimod alfa (Biological)
Saline
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour.
干预措施: Saline (Drug)
结局指标
主要结局
Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead Electrocardiograms (ECGs), and Telemetry Monitoring
时间窗: Up to 42 days after treatment
List of adverse events in the form of frequency and grade. Assessment of safety based primarily on the frequency and nature of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, 12-lead ECGs, and telemetry monitoring from pre-dosing to day 42 visits. The data include all treatment-emergent adverse events (TEAEs) including specific drug-related TEAEs.
次要结局
- Maximum Serum Concentration (Cmax) of CD24Fc(Up to 42 days after treatment)
- Area Under the Serum Concentration Curve From 0-42 Days (AUC 0-42d) of CD24Fc(Up to 42 days after treatment)
- Serum Concentration of CD24Fc Over Time(Up to 42 days after treatment)
- Terminal Elimination Half-Life (t1/2) of CD24Fc(Up to 42 days after treatment)