ACTRN12622000851763招募中1 期
A phase 1,First-in-Human, open-label, Safety, Tolerability and Pharmacokinetic Study of Single-Ascending Doses of VLS-01 in Healthy Adult Volunteers
Viridia Life Sciences Australia Pty Ltd0 个研究点目标入组 48 人开始时间: 2022年6月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Male or female 21 to 45 years of age, inclusive, at time of consent.
- •2. Female participants must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test at admission to the CRU, are not currently breast-feeding, and must meet one of the following criteria:
- •a. Undergone 1 of the following sterilization procedures at least 6 months before the first
- •i. hysteroscopic sterilization
- •ii. bilateral tubal ligation or bilateral salpingectomy
- •iii. hysterectomy
- •iv. bilateral oophorectomy
- •v. Essure sterilization; or
- •b. Be postmenopausal with amenorrhea for at least 1 year before the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
- •c. Female participants of childbearing potential must use at least one of the following protocol-specified highly effective methods or effective methods of birth control and must agree to use barrier contraception (male condom) during heterosexual intercourse, from the time of Screening until at least 90 days after VLS-01 administration as described in the protocol..
- •3. Participant weighs more than or equal to 50 kg and less than or equal to 100 kg and has a body mass index (BMI) more than or equal to 18.0 kg/m2 and less than or equal to 32.0 kg/m2, inclusive, at Screening.
- •4. Participants who smoke no more than 2 cigarettes, pipes, cigars, e-cigarettes or equivalent per week, including nicotine products, can be included in the study but must be willing to abstain from smoking/using nicotine products for 24 hours before VLS-01 administration and during the confinement period.
排除标准
- •Participants who meet any of the following criteria will be excluded from this study:
- •1. Known allergy or hypersensitivity to VLS-01-BU and VLS-01-IV (DMT) or any of the excipients in the formulation.
- •2. History of clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, hypertension, hypotension, bradycardia, or tachycardia. and as determined by the protocol.
- •3. History of seizures, convulsions, or increased intra-cranial pressure with the exception of pediatric febrile seizures.
- •4. Poor venous access for participants administered VLS-01-IV, or participants with existing buccal lesions or abnormalities that could confound the oral administration of VLS-01-BU or the oral examination.
- •5. Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before screening.
- •6. Positive test results for hepatitis B surface antigen, hepatitis C virus antibody, or anti-human immunodeficiency virus (HIV) type 1 antibody; participants with prior recovered HBV infection will be included with confirmed normal liver function tests; and participants with positive hepatitis C virus antibody results, but who have been effectively treated for hepatitis C as evidenced by a negative hepatitis C ribonucleic acid (RNA) confirmation test, and who no longer require antiviral therapy, are eligible for participation.
- •7. Has taken compound(s) known to induce or inhibit cytochrome P450 (CYP) drug metabolizing enzymes (eg, rifampin, cimetidine, or barbiturates) within 30 days before dosing, including herbal supplements, grapefruit juice or products, Seville orange juice or related products, or St. John’s wort.
- •8. Has received a monoamine oxidase inhibitor within 14 days of screening.
- •9. Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) before dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable.
- •10. Has donated blood or plasma within 30 days before screening, or had a loss of whole blood of more than 500 mL within the 30 days before screening, or receipt of a blood transfusion within one year before screening.
- •11. Has experienced symptoms of acute illness or chronic disease within 14 days before Screening, or any disease or condition (medical or surgical) that, by the determination of the PI, might compromise interpretation of safety or PK data, or would place the participant at risk as a result of participation in the study.
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