ISRCTN15814719进行中（未招募）1 期
A single and multiple dose-escalation first-in-human study evaluating the safety, tolerability, and pharmacokinetics of VS-041 in healthy subjects
Vasa Therapeutics Sp. z o. o.0 个研究点目标入组 72 人开始时间: 2024年9月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Males or females 18 to 55 years of age, inclusive at the time of signing the informed consent.
- •2.Subjects considered reliable and capable of adhering to the protocol, visit schedule and medication intake according to the judgment of the PI.
- •3.Subjects with suitable veins for multiple venipuncture/ cannulations as assessed by the PI at Screening.
- •4.Non-tobacco smoker within the previous 6 months (before Screening), and does not use tobacco-containing, or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, e-cigarettes, nicotine patch, or nicotine gum).
- •5.Body weight of at least 50 kg and body mass index (BMI) within the range =19 to =29.9 kg/m².
- •6.Males who are sexually active and whose partners are females of childbearing potential must be either surgically sterile or using a highly effective method of contraception for the duration of the study (from the time they sign informed consent form (ICF) through at least 90 days after administration of the last dose of study drug). Contraceptive use by men should be consistent with ICH GCP E6(R2) 2016 and local regulations regarding the methods of contraception for those participating in clinical studies. These contraception requirements are more conservative than the guidance issued by the CTFG, 2022 related to contraception and pregnancy testing in clinical trials. Males must agree not to donate or bank sperm after they signed consent through 90 days after administration of the last dose of study drug.
- •7.Female subjects must be of non-childbearing potential, who have undergone a sterilization procedure at least 6 months prior to dosing with official documentation (e.g., hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy), or are postmenopausal with amenorrhea for at least 1 year prior to dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status and serum pregnancy test at Screening and upon admission with a negative result as per PI’s judgment. Female subject must agree to not donate eggs after they signed consent through 90 days after administration of the last dose of study drug.
- •8.Able to understand and willing to sign a written ICF.
- •9.Willing and able to comply with trial procedures and restrictions listed in the ICF and in the protocol.
排除标准
- •1.Female study subject who is pregnant or breastfeeding.
- •2.Any clinically significant disease, active malignancy or history of malignancy (excluding basal cell carcinoma) or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal fractures, endocrine including adrenal insufficiency, metabolic, psychiatric, major physical impairment) which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate in the study.
- •3.Any physical or psychological condition which, in the opinion of the PI, would compromise the subject's safety or successful participation in this trial.
- •4.Subjects with a known hypersensitivity to VS-041 or any of the excipients (mannitol, croscarmellose sodium, silica colloidal anhydrous [Aerosil], sodium dodecyl sulfate, sodium stearyl fumarate) of the product.
- •5.Current evidence of COVID-19 infection as determined by the PI (following local practice) or hospitalized with COVID-19 infection within the last 3 months prior to Screening.
- •6.History of drug or alcohol abuse or addiction within 2 years before the start of study medication dosing.
- •7.Positive test results for alcohol at Screening or admission.
- •8.Positive drugs of abuse testing at Screening or admission for the drugs listed in the protocol SoA.
- •9. Use of any medications except for the medications exempted by the PI on a case-by-case basis after they are judged to be unlikely to affect the PK profile of the study medication or subject safety (eg, topical drug products without significant systemic absorption, simple pain killers [eg, acetaminophen/paracetamol up to 2g/24hour]):
- •9.1.Prescription medications within 14 days prior to the first dosing until follow-up visit
- •9.2.Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to the first dosing (except for the occasional use of acetaminophen/ paracetamol [up to 2 g daily]) until follow-up visit
- •9.3.Depot injection or implant of any drug within 3 months prior to the first dosing until follow-up visit
- •10.Subject has an uncontrolled or serious disease, or any medical or surgical condition, deemed by the PI to be likely to interfere with the participation in the clinical study and/or put the subject at significant risk and or to compromise the interpretation of trial results if she/he participates in the clinical study.
- •11.Any laboratory values with the following deviations at the Screening; test may be repeated at the discretion of the PI, if abnormal:
- •11.1.Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody
- •11.2.Alanine transaminase (ALT) > 1.1 x upper limit of normal (ULN)
- •11.3.Aspartate aminotransferase (AST) > 1.1 x ULN
- •11.4.Total bilirubin (TBL) > ULN
- •11.5.Platelet count = lower limit of normal (LLN)
- •11.6.CPK > 2 x ULN
- •12.Abnormal resting vital signs (after resting supine for 5 minutes) of blood pressure (BP), systolic > 140 mmHg or < 100 mmHg or diastolic > 90 mmHg or < 40 mmHg and heart rate (HR) <50 and >90 bpm.
- •13.Study subjects have clinically significant ECG abnormality at
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