A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Single Ascending Doses in Healthy Japanese Men
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pulse
研究概览
简要总结
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses, it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •In good health, determined by:
- •no clinically significant findings from medical history,
- •physical examination,
- •12-lead electrocardiogram (ECG),
- •vital signs measurements,
- •and clinical laboratory evaluations
排除标准
- •History of clinically significant medical conditions including, but not limited to:
- •diseases of the renal,
- •respiratory,
- •gastrointestinal,
- •cardiovascular,
- •neurological,
- •musculoskeletal,
- •immunological,
- •haematological,
- •endocrine,
- •and metabolic systems,
- •as well as oncological,
- •psychiatric,
- •dermatological,
- •and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
研究组 & 干预措施
FE 999301
干预措施: FE 999301 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pulse
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising pulse
QRS axis
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing QRS axis after a single IV dose infusion.
Number treatment-emergent adverse events
时间窗: From baseline up to 36 days after a single dose infusion
Number of treatment-emergent adverse events, including type, intensity, and causality
Heart rate
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead electrocardiogram (ECG) assessing heart rate after a single IV dose infusion.
Change in haematology
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes) from baseline up to and including Day 36 after a single dose infusion.
Blood urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in blood urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Specific gravity urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in specific gravity urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Blood pressure
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising systolic and diastolic blood pressure
RR interval
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing the RR interval after a single IV dose infusion.
QRS duration
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing QRS duration after a single IV dose infusion.
QTc interval
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead electrocardiogram (ECG) assessing QTc interval after a single IV dose infusion.
PR interval
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead electrocardiogram ECG assessing the PR interval after a single IV dose infusion.
QT interval
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing QT interval after a single IV dose infusion.
Glucose urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in glucose urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Body temperature
时间窗: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising body temperature
Clinical chemistry
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotranferase (ALT), albumin, alkaline phosphatase, aspartate aminotranferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltranferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion.
Haemostasis
时间窗: From baseline up to 36 days after a single dose infusion
Blood and urine samples to assess change from baseline in haemostasis after a single IV dose infusion.
pH urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in pH urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Leukocyte urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in leukocyte urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Bilirubin urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in bilirubin urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Nitrate urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in nitrate urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Ketone urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in ketone urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Protein urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in protein urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Urobilinogen urinalysis parameter
时间窗: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in urobilinogen urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
次要结局
- Elimination half-life (t1/2)(From baseline up to 36 days after a single dose infusion)
- Concentration at the end of infusion (Ceoi)(From baseline up to 36 days after a single dose infusion)
- Maximum concentration (Cmax)(From baseline up to 36 days after a single dose infusion)
- Area under the Curve to Infinity (AUCinf)(From baseline up to 36 days after a single dose infusion)
- Area Under the Curve last concentration (AUClast)(From baseline up to 36 days after a single dose infusion)
- Time to reach maximum concentration (tmax)(From baseline up to 36 days after a single dose infusion)
- Mean residence time (MRT)(From baseline up to 36 days after a single dose infusion)
- Clearance (CL)(From baseline up to 36 days after a single dose infusion)
- Volume of Distribution at steady state (Vss)(From baseline up to 36 days after a single dose infusion)