ACTRN12624000737538尚未招募1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of AV-1959R in Healthy Participants
Arvax Pty Ltd0 个研究点目标入组 16 人开始时间: 2024年6月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
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
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Body mass index (BMI) between 18.0 and 32.0 kg/m2 at Screening visit
- •2. Medically healthy with no clinically significant medical history, abnormalities in physical examination, laboratory variables, vital signs, ECG or MRI at the time of Screening and Baseline (if applicable), as deemed by the Investigator or designee.
- •3. Signed informed consent form by the participant prior to initiation of any study-related procedures.
- •4. If female of non-childbearing potential, must meet at least one of the following criteria:
- •4.1. post-menopausal status defined as amenorrhea for at least 12 months prior to study drug dosing in absence of any exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the laboratory defined post-menopausal range.
- •4.2. subject report of surgical sterilization (i.e., hysterectomy, bilateral tubal ligation, bilateral oophorectomy/ salpingectomy) at least 6 weeks prior to Day 1.
- •5. If male, must have had a vasectomy 90 days prior to the Screening visit with a follow up negative sperm count, or agree to not donate sperm for 90 days after the last dose of study drug and, if engaging in vaginal sexual intercourse with a female partner of childbearing potential, agree to use a condom in addition to the female partner must use a highly effective method of birth control (e.g. intrauterine device, diaphragm with spermicide, hormonal contraceptives) throughout the duration of the study treatment period and for 90 days after the last dose of study drug.
- •6. Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
排除标准
- •A subject will be excluded from participation in this study if he or she meets any of the following criteria:
- •1. Any clinically significant medical history or observations at the time of Screening visit not specifically excluded in other criteria that, in the opinion of the Investigator or designee, may confound the results of the study, compromise the safety of the subject or otherwise render the subject unsuitable for participation.
- •2. Magnetic resonance imaging (MRI) showing evidence of any of the following at the Screening:
- •2.1. 1 or more small non-cortical lacunar infarct greater than 1.0 cm
- •2.2. Any territorial infarct including acute or chronic
- •2.3. Subjects who have microbleeds and areas of leptomeningeal hemosiderosis
- •2.4. Subjects who have a presence of any other significant cerebral abnormalities, including Amyloid Related Imaging Abnormalities characterized by edema and effusion (ARIA-E), as assessed in the screening MRI scan.
- •3. Contraindications for MRI scanning, including implanted metallic devices (e.g., non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
- •4. Any serious illness requiring systemic treatment and/or hospitalization within 4 weeks prior to study entry.
- •5. History/evidence of clinically relevant pathology related to the cardiovascular system, respiratory tract, gastrointestinal tract, endocrinology, immunology, hematology, or any other systemic disorder/major surgeries that, in the opinion of the Investigator, would confound participation and follow-up.
- •6. History or presence of any of the following:
- •6.1. clinically significant acute illness or surgery within the previous 3 months of Day 1.
- •6.2. hypersensitivity reaction or anaphylaxis to any medication to be of clinical significance to the current study or compromise the safety of the subject in the opinion of the Investigator
- •6.3. history or suspicion of routine or chronic drug or alcohol abuse or dependence within 1 year prior to Day 1 based on subject report; excessive alcohol intake (defined as routine weekly intake of greater than 21 glasses/units per week, with one unit=150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
- •7. Clinically significant laboratory abnormalities at Screening visit, including (but not limited to):
- •7.1. hemoglobin, hematocrit, total white blood count (WBC) or platelet count below the lower limit of the normal range
- •7.2. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >1.5 times the upper limit of the normal range
- •7.3. serum creatinine above the upper limit of the normal range or estimated creatinine clearance <90 mL/minute as calculated by the Cockcroft-Gault equation
- •7.4. positive testing for human immunodeficiency virus (HIV-1 or -2), hepatitis B surface antigen (HBsAg), or positive testing for hepatitis C (HCV)
- •Clinical laboratory tests may be repeated as per Investigator’s discretion.
- •8. Systolic blood pressure (BP) >160 millimeters of mercury (mmHg), or <90 mmHg; diastolic BP >95 mmHg or <50 mmHg blood at Screening visit or Day 1. Vital signs may be repeated as per Investigator’s judgement.
- •9. Seated heart rate less than 45 beats per minute (bpm) or higher than 100 bpm at the Screening visit or Day 1. Vital signs may be repeated as per Investigator’s judgement.
- •10. ECG with QTcF interval duration equal or greater than 450 msec for males and 470
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