ACTRN12621000644864已完成1 期
A Phase 1, Randomised, Double-Blind Placebo-Controlled, First in Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ANPA-0073 in Healthy Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
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 55 Years（—）
- 性别
- All
入选标准
- •1.Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects
- •2.Adult males and females, 18 to 55 years of age (inclusive) at screening
- •3.Body mass index more than 18.0 and less than 30.0 kg/m2, with a body weight (to 1 decimal place) more than 50 kg at screening
- •4.Be nonsmokers (including tobacco, e-cigarettes and marijuana) for at least 3 months prior to first study drug administration and have a negative test for cotinine at the screening visit and at check-in on Day -1
- •5.Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing at the timepoints indicated in the Schedules of Assessments (SoA), including:
- •a.Physical examination without any clinically significant findings
- •b.Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes in supine position
- •c.Heart rate (HR) in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine position
- •d.Body temperature (tympanic or oral) in the range 35.5 degrees C to 37.7 degrees C (inclusive)
- •e.No clinically significant findings in serum chemistry, haematology, coagulation and urinalysis tests
- •f.Triplicate 12-lead ECG (taken after the volunteer has been supine for at least 5 minutes) with a QT interval corrected using the Fridericia method (QTcF) less than 450 msec for males and less than 470 msec for females and no clinically significant abnormalities
- •6.Female volunteers must:
- •a.Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle-stimulating hormone level more than 40 IU/L at the screening visit), or
- •b.If of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method of contraception from signing the consent form until at least 30 days after the last dose of the study drug
- •7.Male volunteers must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 days after the last dose of study drug
- •8.Have suitable venous access for blood sampling
- •9.Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions
排除标准
- •1.History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant
- •2.Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications
- •3.Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma)
- •4.Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
- •5.Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration
- •6.History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia
- •7.Findings on transthoracic echocardiogram to have LV ejection fraction on less than 50%, more than mild mitral or aortic valvular regurgitation, or more than mild mitral or aortic valvular stenosis
- •8.Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants
- •9.Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit
- •10.Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
- •11.Estimated creatinine clearance (CrCl) less than 60 mL/min using the Cockcroft-Gault formula or serum creatinine more than 1.5-fold above the ULN
- •12.History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer (4.9% Alc./Vol), 100 mL wine (12% Alc./Vol), 30 mL spirit (40% Alc./Vol) within 12 weeks prior to the screening visit
- •13.Positive drugs of abuse or alcohol breath test results at the screening visit or at check-in (Day -1).
- •14.Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, except use of contraceptives and occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days)
- •15.Consumption of grapefruit or Seville orange (or products containing grapefruit or Seville orange) within 10 days prior to the first administration of study drug
- •16.Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic r
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