ACTRN12615001141538进行中（未招募）1 期
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Gerilimzumab when Administered Subcutaneously to Healthy Adult Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1.1.Adult male and/or females, 18 to 45 years of age (inclusive) at the time of screening.
- •2.Medically healthy with clinically insignificant screening results (e.g. laboratory profiles, medical history, ECGs, physical exam) as judged by the PI.
- •3.Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 29.9 (kg/m2) (inclusive).
- •4.Must agree to abstain from alcohol intake 48 hours before administration of study agent and during the inpatient period of the study.
- •5.Negative urine drug screen /alcohol breath test at Day -1.
- •6.Non-smokers who have not smoked any cigarettes within 6 months prior to screening. No current use of any nicotine containing product. Cotinine levels less than or equal to 5ng/mL.
- •7.Voluntary consent to participate in the study.
- •8.Participants using highly effective, double barrier contraception (both male and female partners) during the study and for 4 months following the last dose of gerilimzumab.
- •Males must not donate sperm for at least 4 months post-dose of the last study treatment. Male partners of female patients and female partners of male patients must also use contraception, if they are of childbearing potential.
- •Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
- •Females not of childbearing potential must be post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle stimulating hormone (FSH) level greater than 40 mIU/mL.
排除标准
- •1.Positive testing for TB, HIV, HBsAg, or HCV.
- •2.Have any known malignancy or history of malignancy, except basal cell skin cancer that has been treated with no evidence of recurrence for at least 3 months before Day 1.
- •3.Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- •4.Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study
- •5.Have evidence of any chronic medical condition (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes).
- •6.Use of any prescription or over-the counter medication (with the exception of paracetamol) within 7 days of randomization.
- •7.Have a history of or current elevations in triglycerides that required treatment.
- •8.Any clinically significant laboratory abnormality
- •9.Absolute neutrophil count less than 1500/microliter
- •10.AST or ALT greater than Upper Limit of Normal. One repeat test may be allowed within 7 days at the discretion of the investigator.
- •11.History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration.
- •12.Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- •13.Plasma donation within 7 days prior to the first study drug administration.
- •14.Administration of IP in another clinical trial within 30 days prior to the first study drug administration.
- •15.Females who are pregnant or lactating. Females should not breast feed for 6 months after the last dose of gerilimzumab.
- •16.Surgery within the past three months prior to the first study drug administration determined by the PI to be clinically relevant.
- •17.History of cerebrovascular disease, coronary artery disease, seizures, or unexplained syncope.
- •18.Regular alcohol consumption in males >21 units per week and females greater than 14 units per week (1 unit = 0.5 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- •19.Failure to satisfy the PI of fitness to participate for any other reason.
- •20.Active infection.
- •21.History of recurrent infections.
- •22.Serious local infection or systemic infection within 3 months requiring antibiotic treatment.
- •23.Any acute illness within 30 days prior to Day 1.
研究者
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