ACTRN12621001365853已完成1 期
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RLS103 (CBD-Technosphere® Inhalation Powder) in Healthy Adult Volunteers
Receptor Life Sciences Australia Pty Ltd0 个研究点目标入组 30 人开始时间: 2021年10月8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
- 30
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female volunteers, between 18 and 55 years of age, inclusive at the time of informed consent.
- •2. In good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory tests at Screening. Continued participation in each subsequent treatment period will be at the discretion of Investigator upon review of ongoing safety and compliance assessments.
- •3. BMI between 18 and 32 kg/m2 (inclusive) with a body weight greater than or equal to 50 kg.
- •4. Non-smoker (cigarettes, cigars, e-cigarettes, or nicotine containing products in the 6 months prior to Screening) as confirmed by negative cotinine results (less than 10 ng/mL) at Screening and must be willing to abstain from smoking for the duration of the study.
- •5. Must have no medical contraindication to CBD, including known allergies or hypersensitivities to CBD or the excipients in Cannabidiol Inhalation Powder.
- •6. Must demonstrate the ability to use the inhaler correctly through a training tool (BluHale) and must be able to tolerate inhalation of a placebo powder.
- •7. Females must be non-pregnant and non-lactating, and must use an acceptable, highly effective double contraception from Screening until study completion, including the follow up period. Double contraception is defined as a condom AND one other form of the following:
- •a. Established hormonal contraception (including oral contraceptive pills [OCPs] long acting implantable hormones and injectable hormones) for at least 1 month prior to Screening.
- •b. A vaginal ring or an intrauterine device (IUD).
- •c. Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) for women or vasectomy at least 90 days prior to Screening for men (with appropriate post-vasectomy documentation of the absence of sperm in semen), provided the male partner is a sole partner.
- •Women not of childbearing potential must be postmenopausal for greater than or equal to 12 months. Postmenopausal status will be confirmed through testing of follicle stimulating hormone (FSH) levels greater than or equal to 40 IU/L at Screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible.
- •Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participant complete abstinence for the duration of the study and for 1 month after the last study treatment is acceptable.
- •All women that are not postmenopausal must have a negative pregnancy test at Screening and Day -1 and be willing to have additional pregnancy tests as required throughout the study.
- •Female participants who are in same sex relationships are not required to use contraception.
- •Males must be surgically sterile (more than 90 days since vasectomy with no viable sperm), abstinent, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from Screening until study completion, including the follow-up period. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormo
排除标准
- •1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- •2. Currently using marijuana, marijuana cigarettes, cannabis-related products, or CBD; or have used any of these products within 3 weeks prior to Screening.
- •3. History of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; vascular disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; any pulmonary disease, including bronchospastic respiratory disease, or chronic obstructive pulmonary disease [COPD]; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 mL/min per the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]); thyroid disease; neurologic (including epilepsy) or psychiatric disease, current infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- •4. Use of prescription or nonprescription medications, including vitamins or herbal supplements, within 7 days of Day 1 and until EOS (excluding hormonal contraceptives and acetaminophen, which are not expected to interfere with the study drug).
- •5. Clinically significant abnormal values for hematology, serum chemistry, or urinalysis at Screening as deemed appropriate by the Investigator, including:
- •a. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 1.5 × the upper limit of normal (ULN)
- •b. Total bilirubin greater than 1.5 × ULN unless due to Gilbert’s syndrome or if considered to be normal variability in the absence of other clinically relevant liver impairment, as approved by Medical Monitor
- •6. Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at Screening as deemed appropriate by the Investigator.
- •7. History of respiratory disease including, but not limited to asthma and COPD and must not be under active treatment for an underlying respiratory disease. No family history of bronchial asthma. Not having severe allergic rhinitis.
- •8. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
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