None listed
Conditions
Brief summary
What is this study about The purpose of this study is to investigate how safe and tolerable repeat doses (applied twice daily for 13 days and once on the 14th day) of ZYN002 transdermal gel is in healthy volunteers. The study will look at how the body absorbs the study drug. This will be done by analysing the levels of ZYN002 in your blood at various times following drug administration. Your skin at the application sites and your hands will be checked to see if there is any irritation or reactions present after ZYN002 application. In the study you will be provided with moisturizer to apply to assist with potential dryness of the skin caused by the study treatment. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are in general good health. Study details: This study will investigate various doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff administering the study treatment will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes A screening visit, which could be up to 28 days before your study treatment..Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, C-SSRS assessment and will have several blood and urine samples collected for laboratory analysis. You will report to the clinic your first day of treatment (Day 1). The study treatment will be applied twice daily for 13 days with one treatment on day 14. Days 1-13, each morning while at the research facility, you will apply your AM treatment of ZYN002 or placebo gel. You will apply the study treatment to the treatment site assigned to you (either your left and right shoulder and/or upper arms, or your left and right upper thighs). You will apply your AM dose of all the study drug to clean, dry, intact skin, thoroughly massaging it into the application sites assigned. You will continue to massage study drug into the application site until the application site feels dry to the touch. This will take approximately 2-4 minutes but everyone’s skin is different so it could take less or more time for you. You will repeat this procedure at your home for the afternoon application on Days 1 to 13. You will return to the research facility every morning on Days 1-13 for the AM dose. On Day 14 you will stay at the research facility until the evening of Day 15, 36 hours after the last study treatment. You will return to the research facility on Days 17, 19, 21, 23, 27, 31 and Day 35 for study assessments.
Interventions
A total of 42 eligible subjects will be randomized in 1:1:1:1:1:1:1 ratio to one of the seven treatment cohorts. Then within a cohort, a subject will be further randomized in 2:1 ratio to receive either ZYN002 or placebo. Therefore, six eligible unique subjects will be randomized to a treatment cohort. Within a treatment cohort, four subjects will be randomized to receive ZYN002 and two subjects will be randomized to receive placebo. Participants will be randomised to one of seven treatment grou
A total of 42 eligible subjects will be randomized in 1:1:1:1:1:1:1 ratio to one of the seven treatment cohorts. Then within a cohort, a subject will be further randomized in 2:1 ratio to receive either ZYN002 or placebo. Therefore, six eligible unique subjects will be randomized to a treatment cohort. Within a treatment cohort, four subjects will be randomized to receive ZYN002 and two subjects will be randomized to receive placebo. Participants will be randomised to one of seven treatment groups as indicated below. Treatment A – 10 g of 2.5% ZYN002 or placebo applied twice daily (AM and PM) to right and left upper arms/shoulders (Total active daily dose 500mg) Treatment B – 10 g of 2.5% ZYN002 or placebo applied twice daily (AM and PM) to right and left upper thighs (Total active daily dose 500mg) Treatment C – 10 g of 2.5% ZYN002 or placebo applied twice daily on right and left upper arms/shoulders AM and right and left upper thighs (PM) (Total active daily dose 500mg) Treatment D – 6 g of 4.2% ZYN002 or placebo applied twice daily (AM and PM) to right and left upper arms/shoulders (Total active daily dose 504mg) Treatment E – 6 g of 4.2% ZYN002 or placebo applied twice daily on right and left upper arms/shoulders AM and right and left upper thighs (PM) (Total active daily dose 504mg) Treatment F – 4.7 g of 4.2% ZYN002 or placebo applied twice daily (AM and PM) to right and left upper arms/shoulders (Total active daily dose 394.8mg) Treatment G – 4.7 g of 4.2% ZYN002 or placebo applied twice daily on right and left upper arms/shoulders AM and right and left upper thighs (PM) (Total active daily dose 394.8mg) Participants will receive the same number of treatments of placebo gel as the number of active study drug in order to keep the study blinded. The gel will be thoroughly massaged into right and left upper arms/shoulders or right and left upper thighs by the participant. Once the participant has completed their treatment application they will be instructed to wash their hands thoroughly with soap and water to remove any residual gel. Participants will be instructed to not lay or lean on either shoulder/arm, for at least 30 minutes post dosing/ Subjects will be permitted to shower more than 90 minutes prior to each morning’s dosing.. Dosing period will be 13 days plus one morning dose on day 14. Adherence to treatment will be monitored by empty gel syringe return and collection and review of participant dosing diary.
Sponsors
Zynerba Pharmaceuticals Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: 1. Healthy male or female adults, 18-55 years of age, inclusive, at the time of screening. 2. Judged by the investigator to be in generally good health at screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range, but acceptable, must be documented as not clinically significant (NCS) at the discretion of the investigator. 3. Subjects have a body mass index between 18-34 kg/m2. 4. Females of childbearing potential must have a negative pregnancy test at the Screening Visit and pre-dose on Day 1, Day 7 and Day 14. 5. Subject agrees to abide by all study restrictions and comply with all study procedures. 6. Subject must be adequately informed of the nature and risks of the study and give written informed consent prior to screening. 7. In the investigator’s opinion, the subject is reliable and is willing and able to comply with all protocol requirements and procedures.
Exclusion criteria
Main Exclusion Criteria: Any of the following is considered criterion for exclusion: 1. Females who are pregnant, nursing or planning a pregnancy; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 21 days prior to the first dose of study medication and for 28 days after the last dose of study medication. a. Standard acceptable methods include abstinence or the use of a highly effective method of contraception, including; hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, intrauterine device. 2. Use of tobacco/nicotine-containing products within one month of Screening Visit or during study. 3. Subjects using any prescription drugs except hormonal contraception or herbal supplements within four weeks prior to the Screening Visit or any OTC drugs/vitamins within 72 hours prior to first dose of study medication. 4. Use of cannabis or any CBD-containing product within 4 weeks of Screening Visit or during the study. 5. Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies. 6. Positive drug screen for ethanol, cocaine, Delta 9-tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, and opiates. 7. Any clinically significant condition or abnormal findings at the Screening Visit that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study treatment. 8. Any skin disease or condition, including eczema, psoriasis, melanoma, acne or contact dermatitis, scarring, imperfections, lesions, tattoos or discoloration that may affect treatment application, application site assessments, or affect absorption of the study drug. 9. Use of cosmetics on the shoulder/upper arms or thighs, during the study period. 10. History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any adhesives, compound, or chemical class related to ZYN002 or its excipients. 11. Has taken grapefruit products within the last four weeks or during the study. 12. History of treatment for, or evidence of alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of two units of alcohol per day until the End of Study Visit. 13. History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements. 14. Has suspected or confirmed cardiovascular disease. 15. Participation in any investigational product or device study within 30 days prior to Screening Visit (except clinical study ZYN2-CL-01 or ZYN2-CL-02), or is scheduled to participate in an investigational device or another investigational drug study during the course of this study. 16. Patient has a history of actual suicide attempt in the last 5 years or more than one lifetime suicide attempt. 17. Patient responded “yes” to Question 4 or 5 of C-SSRS during Screening. 18. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
Outcome results
None listed