ACTRN12617001426370已完成1 期
A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PTG-200 in Normal Healthy Male Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
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
- Male
入选标准
- •1.Male normal healthy volunteers (NHV), age 18 to 55 years, inclusive.
- •2.Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study drug.
- •3.Participants must have a Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive.
- •4.Participants must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator.
- •5.Male participants with female partners should use a condom during sexual intercourse for 3 months after the last dose of study drug. In addition, male participants with female partners must agree to use a second highly-effective method of contraception (e.g. hormonal contraception or an intrauterine device) for 3 months after the last dose of study drug.
- •6.Participants must be a non-smoker, and must not have regularly used nicotine products within six months prior to screening; those who have had social or accidental exposure to nicotine/nicotine-containing products over the 3 months prior to screening may be enrolled in the study at the discretion of the Investigator.
- •7.Participants must have no dietary restrictions, and be willing to consume the standard meals provided.
- •8.Participants must have the ability and willingness to attend the necessary visits to the study centre.
- •9.Written informed consent signed prior to entry into the study.
排除标准
- •1.History of clinically significant endocrine, neurological, gastrointestinal, cardiovascular, haematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. Participants with a history of gastrointestinal disease including inflammatory bowel disease (IBD), toxic megacolon, dysplasia, gastroesophageal reflux disease (GERD), colon cancer, intestinal stenosis, or fistula will be excluded. History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps) will be excluded. Note: NHVs with histories of uncomplicated kidney stones or childhood asthma may be enrolled in the study at the discretion of the Investigator.
- •2.History of neoplastic disease, with the exception of adequately treated non melanomatous skin carcinoma.
- •3.Mentally or legally incapacitated, has significant emotional problems at the time of Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: NHVs who have had situational depression may be enrolled in the study at the discretion of the Investigator.
- •4.Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening; evidence of intestinal infection within 30 days prior to screening.
- •5.History of severe allergic or anaphylactic reactions
- •6.Blood pressure (BP) >140/90 mm Hg or heart rate (HR) >100 beats per minute at Screening and at Day -1
- •7.Clinically significant laboratory abnormalities including:
- •a) Impaired renal function (serum creatinine levels >106 µmol/L) at Screening; estimated creatinine clearance (CrCl) of <80 mL/minute based on the Cockcroft-Gault equation below:
- •Males: CrCl = (140 - age [years]) (body weight [kg])/(72)(serum creatinine [mg/dL])
- •b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values >1.2 × upper normal limits
- •8.Clinically significant abnormality on ECG performed at the Screening Visit or prior to administration of the initial dose of study drug. (Screening and predose ECG conduction intervals must be within gender specific normal ranges [QT interval corrected for heart rate (QTc) in males less than or equal to 450 msec], however participants with out of normal range PR which is deemed not clinically significant by the PI may be enrolled).
- •9.Positive test for hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody at Screening. Patients positive for hepatitis C antibody are excluded unless they have had a history of sustained virologic response 12 weeks (SVR12) after the end of treatment for a prior infection.
- •10.Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol (THC), amphetamines, benzodiazepines, opiates and cocaine).
- •11.Participants with a history of substance abuse or dependency or history of recreational intravenous drug use (by self-declaration).
- •12.Regular alcohol consumption by males defined as >21 alcohol units per week (where 1 unit = 284 mL of beer, 25 ml of 40% spirit or a 125 ml glass of wine).
- •13.Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal remedies (such as St. John’s Wort [Hypericum perforatum]), beginning 14 days (or 5 half-lives, whichever is longer) before admini
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