A study of RLS103 (CBD-Technosphere® Inhalation Powder) in Healthy Adult Volunteers

Inclusion Criteria18

• Healthy male or female volunteers, between 18 and 55 years of age, inclusive at the time of informed consent.
• 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.
• BMI between 18 and 32 kg/m2 (inclusive) with a body weight greater than or equal to 50 kg.
• 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.
• Must have no medical contraindication to CBD, including known allergies or hypersensitivities to CBD or the excipients in Cannabidiol Inhalation Powder.
• 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.
• 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 hormones, injectable hormones, a vaginal ring, or an IUD. Participants with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle.
• Males must not donate sperm for at least 90 days after the last dose of study drug.
• Must have the ability and willingness to attend the necessary visits to the CRU.
• Must sign an informed consent form (ICF) indicating that they understand the purpose of the study and the procedures required for the study and are willing to participate in the study.