2021-PT054: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin Via Intravenous Administration in Healthy Subjects.
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
- Number of subjects with treatment related adverse events assessed according to CTCAE v5.0 of one single intravenous dose of HutrukinTM in healthy subjects at each dose level.
研究概览
简要总结
The study will be a Phase I, open label, safety and pharmacokinetics study of HutrukinTM in at least eight healthy subjects in each of the three dose cohorts (1,000 mg, 3,000 mg and 5,000 mg).
详细描述
Study Title: A Randomized Phase I Open-Label, Placebo-Controlled, Dose Escalation Study to Evaluate Safety and Pharmacokinetics of Hutrukin via Intravenous Administration in Healthy Subjects
Sponsor: XBiotech USA, Inc.
Study Chair: Neha Reshamwala, MD
Number of Planned Subjects: 24 healthy subjects with 8 subjects in each of the dose cohorts of HutrukinTM.
Approximate Duration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥18 and weight ≥40 kg.
- •Adequate bone marrow function defined as:
- •absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 109/L)
- •platelet count > 150,000/mm3
- •hemoglobin of ≥ 10 g/dL
- •Adequate renal function, defined by serum creatinine ≤ 1.5 x lab ULN.
- •Adequate hepatic function defined as:
- •serum albumin ≥ 3.0 g/dL
- •total bilirubin ≤ 1.5 times lab ULN.
- •alanine aminotransferase (ALT) ≤ 2.0 times lab ULN.
- •aspartate aminotransferase (AST) ≤ 2.0 times lab ULN
- •For female subjects of childbearing potential WOCBP, a negative pregnancy test at screening and the female subjects must agree to either abstain from sexual intercourse or use reliable, effective contraception such as hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, or use of a condom by their partner. Women of non-childbearing potential include those who cannot get pregnant medically, including post-menopausal women and those with a history of hysterectomy or surgical sterilization.
- •Male participants must agree to abstain from sexual intercourse or use a reliable, effective contraceptive method, such as condoms, or have had a vasectomy. Alternatively, female partners of male subjects enrolled in the study must use reliable, effective contraception such as hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, or contraceptive sponge.
- •Signed and dated Institutional Review Board (IRB) approved informed consent before any protocol-specific screening procedures are performed.
排除标准
- •Treatment with any biologicals (including intravenous immunoglobulin) or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer).
- •Uncontrolled or significant cardiovascular disease, including:
- •A myocardial infarction within the past 6 months.
- •Uncontrolled angina within the past 3 months.
- •Congestive heart failure within the past 3 months, defined as New York Heart Association (NYHA) Class II or higher.
- •Uncontrolled hypertension (blood pressure >160 mm Hg systolic or >100 mm Hg diastolic).
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
- •Treatment with immunosuppressant agents, including corticosteroids or cyclosporine within the last 4 weeks.
- •History of any clinically significant medical disorders the investigator decides should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
- •Abnormal ECG with any clinically significant findings or with QTc >470 ms.
- •Serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 3 months prior to the screening visit.
- •Infectious disease:
- •Positive HIV, RPR, Hepatitis B or C, TB (QuantiFERON-TB Gold (QFT)/ IGRA)
- •History of immunodeficiency.
- •Female subjects who are pregnant, planning to become pregnant during the course of the study, or breast-feeding.
- •Major surgery within 28 days prior to Day
- •History of progressive multifocal leukoencephalopathy (PML) or other demyelinating disease.
- •History of malignancy before screening with the exception of squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix.
研究组 & 干预措施
Placebo
At least two healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered placebo.
干预措施: Placebo (Biological)
Hutrukin
At least six healthy subjects in each of the three dose cohorts (1000 mg, 3000 mg, and 5000 mg), will be administered Hutrukin.
干预措施: Hutrukin (Biological)
结局指标
主要结局
Number of subjects with treatment related adverse events assessed according to CTCAE v5.0 of one single intravenous dose of HutrukinTM in healthy subjects at each dose level.
时间窗: 28 days
Participants will be monitored for acute reactions, blood chemistry and hematology immediately after dosing and at multiple time points up to 28 days. All adverse events will be documented at multiple time points and assessed in terms those possibly, probably and definitely related to test article according to CTCAE v5.0 criteria. Anti-drug antibodies (ADA) will also be evaluated.
次要结局
- Half-life(28 days)
- Plasma concentration at various time points including terminal concentration(28 days)
- Total exposure(28 days)
- Maximum plasma concentration of test article(28 days)