Phase 1 study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of AJM300 in healthy male subjects - randomised, double-blind, controlled trial

EA Pharma Co., Ltd.0 个研究点目标入组 32 人开始时间: 2019年10月28日最近更新: 2023年10月17日

试验速览

AJM300 was of no safety concern at single doses of 40 to 320 mg in healthy male adult subjects.

•Main inclusion criteria
•- Japanese healthy male adults aged 20 or older to 55 and under, when consented.
•- BMI: 18.5 to under 25.0 kg/m2
•- No clinical concerns in the examinations and physiological and clinical laboratory tests at screening.
•Subjects with laboratory values deviating from the center's standards that the investigator or a subinvestigator judged to be eligible to participate.
•- Subjects who could consented in writing

•Main exclusion criteria
•- Subjects with past history of diseases which are likely to seriously affect absorption, distribution, metabolism, and excretion of the investigational product or surgical history of digestive or biliary tract
•- Subjects complicated by gastrointestinal disease
•- Subjects with past history of drug allergy
•- Smoking subjects or subjects who stopped smoking within 3 months
•- Subjects with past history of drug or alcohol dependence or present illness
•- Subjects positive for HBs antigen, anti-HCV antibody, and anti-HIV-1 and -2 antibody, or positive in the serologic test for syphilis
•- Subjects using other prescription drugs within 28 days or using OTC drugs or vitamins within 3 days before treatment with the investigational product

发起方