ACTRN12618000896279已完成1 期
A Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145548 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
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
- 25 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Participant must be 25 to 55 years of age, inclusive, at the time of signing the informed consent.
- •2. Participants who are overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure (BP) and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- •3. Body weight of at least 50 kg and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive).
- •4. Male or Female
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •a. Male participants
- •Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days (a spermatogenesis cycle) after administration of study drug:
- •Refrain from donating sperm
- •PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- •Must agree to use a highly effective method of contraception with their partner(s) of childbearing potential. Their female partner(s) of childbearing potential must also agree to use a highly effective form of contraception for the same period.
- •b. Female participants:
- •Female participants must be of non-childbearing potential as defined by one of the following:
- •Surgical sterilization by hysterectomy removal of uterus), bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes) or bilateral oophorectomy (removal of both ovaries) at least 6 months prior to dosing
- •Post-menopausal with amenorrhea (absence of menstrual periods) for at least 1 year prior to dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status
- •5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •1. Have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- •2. Have a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration
- •3. Have a history of meningococcal infection, or a first-degree relative with a history of meningococcal infection
- •4. Current or chronic history of liver disease or known hepatic or biliary abnormalities (including biliary cholestasis or Gilbert's syndrome)
- •5. Subjects with a female partner who is pregnant, nursing, or planning to become pregnant during the confinement phase of the study or within 90 days of study drug administration.
- •6. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
- •7. History of hypersensitivity reactions to beta-lactams, penicillin, aminopenicillins, fluoroquinolones, cephalosporins, and carbapenems
- •8. Use of prohibited over-the-counter or prescription medications as follows:
- •Prescription medications (systemic and topical) within 14 days prior to first study drug administration (or when known, 5 half-lives, whichever is longer) through study completion, including follow-up visits
- •Non-prescription medications (including lipid-soluble vitamins A, D, E, and K [water-soluble vitamins B and C are not prohibited], herbal supplements, and dietary supplements) within 14 days of first study drug administration
- •Medications known to induce or inhibit hepatic microsomal enzyme cytochrome P450 (CYP450) activity (e.g., quinines) within 28 days of first study drug administration
- •Hormonal therapy/replacement medications within 28 days of first study drug administration
- •9. Live attenuated vaccine within 30 days or other vaccine within 14 days of first study drug administration
- •10. Donated blood or lost more than 500 ml of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration
- •11. Current enrolment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
- •12. Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to dosing
- •13. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
- •14. Positive human immunodeficiency virus (HIV) antibody test
- •15. Positive serum hCG (female participants only)
- •16. Have clinically significant laboratory abnormalities, including any of the following, at either screening or Day -1 :
- •Serum creatinine greater than ULN and/or creatinine clearance less than 80 mL/minute estimated by the Cockcroft-Gault formula [(140 - age) × weight (kg) / 72 × serum creatinine (mg/dL)]
- •Alanine transaminase greater than ULN
- •Aspartate transaminase greater than ULN
- •Alkaline phosphatase greater than ULN
- •Total bilirubin greater than 1.5 × ULN
- •Absolute neutrophil count (ANC) less than lower limit of normal (LLN)
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