A Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0144471 in Healthy Volunteers

Achillion Pharmaceuticals, Inc.0 个研究点目标入组 46 人开始时间: 2016年5月3日最近更新: 2020年1月13日

适应症

试验速览

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•1. Healthy male and female subjects of any ethnic origin between the ages of 25 and 55 years, inclusive
•2. Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
•3. Female subjects must be of non-childbearing potential
•4. Male subjects must agree to abstinence or use a condom when engaged in sexual activity

•1. History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease in the opinion of the Principal Investigator (PI)
•2. Any condition possibly affecting drug absorption (including gastrectomy or cholecystectomy)
•3. Subjects with C3 complement protein (C3) or C4 complement protein (C4) >110% of the upper limit or <90% of the lower limit of the reference ranges at Screening
•4. Subjects with alternative pathway hemolysis (AH50), or classical pathway hemolysis (CH50) assay results outside the reference ranges at Screening
•5. Body temperature greater than or equal to 38 degrees C on Day – 1 or Day 1, Hour 0
•6. History of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration
•7. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection
•8. Current tobacco users and smokers (defined as the use of any tobacco or nicotine-containing product within 3 months prior to first study drug administration) or a positive cotinine test at Screening or Day -1
•9. History of hypersensitivity reactions to beta-lactams, penicillin, aminopenicillins, flouroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems.

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