CTRI/2024/04/065934尚未招募1 期
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of VGA039 Following Intravenous or Subcutaneous Administration of Single Ascending Doses in Healthy Adults and Adult Patients with von Willebrand Disease - VEGA
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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
入选标准
- •Subjects are eligible for the study only if all the following criteria are met, as applicable:
- •1. Adult male and female subjects, 18 to 60 years of age, inclusive.
- •2. Female subjects of childbearing potential must have a negative serum pregnancy test during Screening, a negative urine pregnancy test pre-dose on Day 1, and be willing to use a highly effective method of contraception or 2 other methods of contraception, excluding hormonal contraceptives, unless where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject, from the time of administration of the study drug until 3 months post-dose. Note: for the purposes of this study, a female subject of non-childbearing potential is defined as the subject being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilization (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy) confirmed by follicle-stimulating hormone (FSH) level > 40 mIU/mL at Screening.
- •3. Male subjects (and partners of childbearing potential) must be willing to use a highly effective method of contraception or 2 other effective methods of contraception, unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject, from the time of administration of the study drug until 3 months post-dose.
- •4. No clinically significant history of previous allergy / sensitivity to VGA039 or any of the excipients contained within the investigational medicinal product (IMP).
- •5. Subjects with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV Ab) test results at Screening. Subjects who are HCV Ab-positive with a HCV RNA test result that is negative/below the limit of detection will be eligible.
- •6. No clinically significant abnormalities in 12-lead ECG determined at Screening.
- •7. No clinically significant abnormalities in vital signs (blood pressure, pulse rate,
- •respiration rate, oral temperature) determined at Screening.
- •8. Subjects must be available to complete the study (including all follow-up visits).
- •9. Subjects must provide written informed consent to participate in the study.
- •10. Subjects must have been vaccinated for COVID-19 (as defined by being at least 2 weeks after receiving a second dose of a COVID-19 vaccine requiring 2 doses for initial immunization, or at least 2 weeks after receiving the only dose of a COVID-19 vaccine requiring a single dose for initial immunization), or have documentation in their medical record of prior COVID-19 infection that started at least 2 weeks prior to Screening and now confers natural immunity.
- •11. Subjects must have a negative COVID-19 test result within 24 hours before
- •administration of the study drug.
- •Additional Inclusion Criteria (for Subjects in Part 1 Only)
- •12. Healthy volunteers with a body mass index (BMI) of 18-32 kg/m2, inclusive.
- •13. Hemoglobin level = 12 g/dL and platelet count = 150 × 109/L at Screening.
- •14. No clinically significant abnormal test results for serum biochemistry, hematology (except hemoglobin level, as above), coagulation, and/or urine analyses at Screening.
- •15. Subjects with negative urinary drugs of abuse (DOA) screen test results, determined at Screening. A positive test result
排除标准
- •Subjects meeting ANY of the following exclusion criteria are NOT eligible to be enrolled into the study:
- •1. Use of prescription or non-prescription drugs, vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to administration of the study drug, that, in the opinion of the Investigator and Sponsor Medical Monitor, will interfere with the study procedures, affect platelet or coagulation function, or compromise subject safety.
- •2. Use of hormonal contraceptives within 56 days or 5 half-lives (whichever is longer) prior to administration of the study drug.
- •3. Detection of FV Leiden or Prothrombin G20210A mutation, or laboratory results consistent with protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
- •4. Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
- •5. History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.
- •6. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.
- •7. A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units for male and female subjects of alcohol a week) within the past 2 years.
- •8. Current tobacco smoker and/or nicotine user, given that these are independent risk factors for thromboembolism.
- •9. Inability to communicate well with the Investigators (i.e., language problem, poor mental development, or impaired cerebral function).
- •10. Participation in a new chemical or biological entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the administration of the study drug. (Washout period between studies is defined as the period of time elapsed between the last dose of study drug in the previous study and the first dose of study drug in the next study).
- •11. Subjects who have received investigational vaccines (except for COVID-19 vaccines only approved for emergency use) or vaccines contraindicated in the
- •immunocompromised within 28 days before administration of the study drug.
- •12. Donation of 450 mL or more blood within the month before the administration of the study drug.
- •13. Any condition in the opinion of the Investigator that may preclude full trial participation and/or completion of assessments for safety, PK, or clinical effect.
- •14. Subjects with presence or history of malignant tumors within the last 3 years, within the exception of basal cell carcinoma of the skin, if medically controlled.
- •Additional Exclusion Criteron (Subjects in Part 1 Only)
- •15. Baseline FVIII activity > 150 IU/dL.
- •Additional Exclusion Criteria (Subjects in Part 2 Only)
- •16. Baseline FVIII activity > 50 IU/dL.
- •17. Any acute, clinically significant bleeding event requiring surgical or procedural
- •intervention within 7 days prior to receiving study drug.
- •18. Refusal to receive blood products if clinically indicated.
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