ACTRN12623000291684已完成1 期
A phase 1, randomised, double-blind, placebo-controlled, study to evaluate the safety, tolerability and pharmacokinetics of MAP 315 in healthy adults
Microba Pty Ltd0 个研究点目标入组 32 人开始时间: 2023年3月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
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 65 Years（—）
- 性别
- All
入选标准
- •1.Male or female participants aged between 18 to 65 years inclusive at Screening.
- •2. The participants must be in good general health, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, vital signs, safety laboratory tests and cardiac monitoring at Screening, and/or before administration of the initial dose of the study drug (active or placebo).
- •3. The participants must weigh greater than or equal to 50 kg and have a body mass index (BMI) between 18 and 32 kg/m2 inclusive at Screening.
- •4.The participants must agree to abstain from alcohol intake and must agree to not consume poppy seeds from at least 48 hours before the initial administration of the study drug, during all the confinement period, and from at least 48 hours prior to any scheduled site visits.
- •5.The participant must agree to follow the dietary requirements for the study including not consuming probiotics and/or nutraceuticals from 28 days before initial study drug administration to the end of the study.
- •6.The participant must agree to continue their normal diet (excluding, as applicable, the limitations required for study participation) from Screening to the end of study visit.
- •7.The participant must have the ability and willingness to attend the necessary visits to the study centre.
- •8.The participant must sign a written informed consent prior to undergoing any of the study-specific procedures, including Screening procedures.
- •9.Male and Female participants must agree to the contraception requirements of the study. Females must be nonpregnant and nonlactating,
- •10.Women of childbearing potential must have a negative pregnancy test at Screening and admission and be willing to have additional pregnancy tests as required throughout the study.
- •11.Participants are non-smokers (have last smoked more than 30 days prior to Screening and no longer smoking, or have never smoked), or smoke no more than the equivalent of 5 cigarettes per day since at least 30 days prior to Screening. If users of other nicotine products (ie, spray, patch, e-cigarette) no more than the equivalent of 5 cigarettes per day since at least 30 days prior to Screening is allowed. Subjects must agree to abstain from smoking while in the CRU.
排除标准
- •1. The participant has a medical history of or a positive test for human immunodeficiency
- •virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBcAg) or
- •hepatitis C virus (HCV) antibodies at Screening.
- •2. The participant is immunocompromised as a result of conditions and/or treatments.
- •3. The participant has any past or current history of gastrointestinal tract (GIT) and/ or
- •bowel disease. Participants with a history of simple appendectomy and/or
- •cholecystectomy are eligible to be included in the study.
- •4. The participant has any underlying physical or psychological medical condition that, in
- •the opinion of the Primary Investigator (PI), would make it unlikely for them to complete the study.
- •5. The participant has evidence of any current chronic medical condition (eg, hypertension,
- •elevated cholesterol/triglycerides, asthma or diabetes, unless as specified in the protocol).
- •6. The participant uses or is planning to use any anti-inflammatory (with the exception of
- •paracetamol/acetaminophen up to 3000 mg per day), antibiotic, antifungals,
- •acetylsalicylic acid (aspirin) and/or any nonsteroidal anti-inflammatory drugs (NSAIDs)
- •within 28 days prior to the initial study drug administration and/or any other prescription
- •or over-the-counter (OTC) medicines (with the exception of oral contraceptives) within
- •seven days prior to the initial study drug administration, unless in the opinion of the PI, local
- •MM and Sponsor medical representative the medication will not interfere with the study
- •procedures or compromise participant safety.
- •7. The participant has any clinically significant laboratory abnormality at Screening or on
- •Day -1 per protocol unless not clinically significant at the discretion of the PI.
- •8. The participant has a history of or current alcoholism or drug abuse within the 1 year
- •prior to the initial study drug administration. Alcohol abuse is defined as greater than 21 standard drinks per week for males, and greater than 14 standard drinks per week for females.
- •9. The participant has donated blood whole blood (greater than 499 mL), has had a significant blood loss ( greater than 499 mL) within 30 days prior to the initial study drug administration, or has donated plasma within 2 weeks prior to the initial study drug administration.
- •10. The participant has severe asthma or chronic obstructive pulmonary disease (COPD).
- •Participants with a past history of childhood asthma and/or current history of mild
- •asthma that is anticipated not to require treatment during the study period will be allowed
- •to participate in the study.
- •11. The participant has been dosed in a clinical trial within 30 days before the initial
- •administration of the study drug; used any experimental therapy within 30 days or 5
- •half-lives prior to the initial administration of the study drug, whichever is greater; or used any biologic therapy within 12 weeks or 5 half-lives prior to the initial administration of the study drug, whichever is greater.
- •12. Females who are pregnant or lactating.
- •13. The participant has had any clinically significant surgery within the 3 months prior to the
- •initial study drug administration that is determined by the PI to have a potential impact
- •on study participation.
- •14. Participants having received vaccination within 14 days to 28 days (as defined in the protocol) of the anticipated start of the Dosing Period and/or are expected to be vaccinated during the Dosin
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