A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
研究概览
简要总结
This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a double blinded study.
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
- •Participants who are generally healthy as determined by medical evaluation
- •Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants
- •Body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m^2) (inclusive)
- •Male and female participants
- •Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and descendant of 2 ethnic Chinese parents and 4 ethnic Chinese grandparents; and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening.
- •Participants of Japanese ancestry are eligible if born in Japan and descendant of 2 ethnic Japanese parents and 4 ethnic Japanese grandparents; and have lived outside Japan for less than 10 years at the time of screening.
- •Participants of White/European ancestry are eligible if self-identified as being of White/European ancestry, (that is [i.e.], from the original peoples of Europe) irrespective of current place of residence; and descendant of 2 parents and 4 grandparents of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth or current place of residence.
排除标准
- •History or presence of 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.
- •Current or chronic history of liver or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones.
- •History of pancreatic injury, pancreatitis or other pancreatic disease; history of Type one Diabetes Mellitus (T1DM) or positive glutamic acid decarboxylase auto-antibodies, or major Type two Diabetes Mellitus (T2DM) complications including severe gastroparesis and autonomic neuropathy.
- •Abnormal blood pressure (defined as systolic Blood Pressure [BP] more than equal [>=]140 millimeters of mercury [mmHg] or diastolic BP >=90 mmHg measured based on the average of triplicate BP readings).
- •History of metabolic bone disorders including osteoporosis, osteopenia, or osteomalacia.
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- •Alanine transaminase (ALT) more than (>)1.5 * upper limit of normal (ULN).
- •Total bilirubin >1.5 * ULN
- •Known bleeding disorder.
- •History of immunodeficiency diseases, including a positive test result for human immunodeficiency virus (HIV).
- •Corrected QT Interval using Fridericia's Formula (QTcF) >=450 millisecond (msec)(male) or >=470 msec (female) at Screening Visit based on the average of triplicate ECGs.
- •Use of statins, other lipid lowering medications or hypertension medications unless on a stable dose for at least 3 months.
- •Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever was longer; or longer if required by local regulations.
- •Participants who have received native FGF21 or a FGF21 analog at any time in the past.
- •Intended use of over the counter (OTC) or prescription medication (including herbal medications) within 7 days prior to dosing and for the duration of study participation.
- •Live vaccine within 14 days prior to dosing and non-live vaccines for 7 days prior study dosing.
- •Current enrolment or participation in another clinical trial within the last 30 days before signing consent of current study.
- •Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening or within 3 months prior to the first dose of study intervention
- •A positive pre-study drug/alcohol screen
研究组 & 干预措施
Placebo in participants of Japanese Ancestry
Healthy participants of Japanese ancestry will be randomized to receive Placebo.
干预措施: Placebo (Drug)
Placebo in participants of White/European Ancestry
Healthy participants of White/European ancestry will be randomized to receive Placebo.
干预措施: Placebo (Drug)
Efimosfermin alfa in participants of Chinese Ancestry
Healthy participants of Chinese ancestry will be randomized to receive efimosfermin alfa.
干预措施: Efimosfermin alfa (Drug)
Efimosfermin alfa in participants of Japanese Ancestry
Healthy participants of Japanese ancestry will be randomized to receive efimosfermin alfa.
干预措施: Efimosfermin alfa (Drug)
Placebo in participants of Chinese Ancestry
Healthy participants of Chinese ancestry will be randomized to receive Placebo.
干预措施: Placebo (Drug)
Efimosfermin alfa in participants of White/European Ancestry
Healthy participants of White/European ancestry will be randomized to receive efimosfermin alfa.
干预措施: Efimosfermin alfa (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)
时间窗: Up to 90 days
Number of participants with clinically significant changes in hematology, chemistry and urinalysis parameters
时间窗: Up to 90 days
Number of participants with clinically significant changes in vital signs
时间窗: Up to 90 days
Number of participants with clinically significant changes in 12 Lead electrocardiogram (ECG)
时间窗: Up to 90 days
Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa
时间窗: Up to 90 days
Area under the serum drug concentration versus time curve from time zero extrapolated to infinity (AUC[0-inf]) of efimosfermin alfa
时间窗: Up to 90 days
Maximum observed serum drug concentration, determined directly from the serum concentration-time data (Cmax) of efimosfermin alfa
时间窗: Up to 90 days
次要结局
- Area under the serum drug concentration versus time curve from time zero to 45 days [AUC(0-45days)] of efimosfermin alfa(Up to 45 days)
- Area under the serum drug concentration versus time curve from time zero to 60 days [AUC(0-60days)] of efimosfermin alfa(Up to 60 days)
- Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa(Up to 90 days)
- Apparent terminal phase half-life (t1/2) of efimosfermin alfa(Up to 90 days)
- Area under the serum drug concentration versus time curve from time zero to 90 days [AUC(0-90days)] of efimosfermin alfa(Up to 90 days)
- Time of last quantifiable plasma drug concentration (Tlast) of efimosfermin alfa(Up to 90 days)
- Apparent clearance (CL/F) of efimosfermin alfa(Up to 90 days)
- Apparent volume of distribution (Vz/F) of efimosfermin alfa(Up to 90 days)
- Apparent terminal phase elimination rate constant (Lambda_z) of efimosfermin alfa(Up to 90 days)