A safety study of BTX1503 Solution in Healthy Volunteers
An Open-Label Study to Evaluate the Safety and Tolerability of BTX1503 Solution in Healthy Volunteers
Botanix Pharmaceuticals Ltd
24 participants
May 8, 2017
Interventional
Conditions
Summary
Purpose The purpose of this study is to investigate how safe and tolerable single and repeat doses of BTX1503 solution are in healthy volunteers. The study will look at whether the body adsorbs cannabidiol (CBD). by analysing the levels of CBD in blood at various times after drug administration. The application site will also be monitored for reactions and irritation. Study participants Healthy adults, aged between 18 and 65 years, inclusive, will participate. Experimental Treatment The study will investigate single and multiple doses of BTX1503 solution applied to the face. The components of BTX1503 have all been used in products that are applied to the skin. There will be four (4) different treatment cohorts with up to six (6) participants in each cohort. Cohort 1: 1 mL of BTX1503 5% Solution will be applied as a single dose in the first part of the study and then, after washout period, a single application will occur each day in the clinic for 14 days during the second part of the study. Cohort 2: 1 mL of BTX1503 5% Solution will be applied twice on Day 1 (12 hours apart) in the first part of the study and then, after washout period, twice daily applications will occur (one in the clinic and one self-applied) for 14 days during the second part of the study. Cohort 3: 3 mL of BTX1503 5% Solution will be applied as a single dose in the first part of the study and then after washout period, a single application will occur each day in the clinic for 14 days during the second part of the study. Cohort 4: 3 mL of BTX1503 5% Solution will be applied twice on Day 1 (12 hours apart) in the first part of the study and then after washout period twice daily applications will occur (one in the clinic and one self-applied) for 14 days during the second part of the study. The study consists of a Screening Visit (up to 14 days before receiving the study treatment), a confinement visit starting on the morning of Day 1 and lasting approximately 24 hours, daily applications at the clinic on Day 8 through Day 20, a second confinement on Day 21 lasting 24 hours and 1 follow up visit on Day 23. The maximum study duration for any participant from screening visit to last clinic visit is 37 days. Tests and procedures which are conducted at some, or all visits during the study include: a brief review of your body systems, vital signs measured, blood and urine sampling.
Eligibility
Inclusion Criteria19
- Participant (or legal guardian) has the ability and willingness to sign a written informed consent.
- Participant is of either gender between 18 and 65 years of age, inclusive.
- Participant is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the investigator.
- Participant has suitable venous access for blood sampling.
- Participant is able and willing to complete the study and to comply with all study instructions and attend the necessary visits.
- Participant must be willing to use the facial cleansers provided (Dove or Neutrogena soap) throughout the study.
- Participant must be willing to refrain from using facial products other than the facial cleansers provided, shaving cream, and sunscreens. Shaving cream and cleansers cannot be used within 5 minutes prior to, or for 4 hours after application of study medication; sunscreens cannot be applied less than 4 hours prior to or after application of study medication.
- Participant must be willing to refrain from use of facial make-up throughout the study except for eye make-up and lipstick.
- Participant agrees to not use marijuana products throughout the study.
- Male participants and their partners must agree and commit to use a barrier method of contraception.
- A negative urine pregnancy test (UPT) result for all women.
- Sexually active women must agree to use:
- a. One of these highly effective contraception methods
- i. Intrauterine device (IUD); hormonal (injections, implants, transdermal patch, vaginal ring; tubal ligation; partner vasectomy, OR
- b. Oral contraceptives WITH a barrier method (listed below), OR
- c. Two barrier forms of contraception (listed below)
- i. Male or female condom; diaphragm; cervical cap; contraceptive sponge.
- Males participants must refrain from sperm donation during the study treatment period until 90 days post study drug administration.
- Male participants must agree to keep their face clean shaven throughout the study and use the same method for shaving as was used for the 4 weeks prior to the Screening Visit.
Exclusion Criteria13
- Female participants who are pregnant, trying to become pregnant, or breast feeding.
- Participant with history of known or suspected intolerance to dimethicone containing products, or drug product excipients (hexamethyldisiloxane, polymethylsiloxane, and polypropylene glycol (PPG) 15 stearyl ether).
- Participant has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit. A urine drug test positive for THC will exclude the participant.
- Participant has sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality which impacts the ability to evaluate the skin of the face.
- Participant has clinically significant skin diseases that may contraindicate participation, including psoriasis, eczema, atopic dermatitis, moderate to severe acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer.
- Participant has had any major illness within 4 weeks of the Screening Visit.
- Participant has any clinically significant abnormal laboratory assessment(s) (blood counts, chemistry, or urinalysis), that, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.
- Participant has known HIV infection.
- Participant has a clinically relevant history of or current evidence of abuse of alcohol or other drugs. If the urine drug screen at the Screening Visit is positive for any drugs of abuse, the participant is not eligible to participate.
- Participant has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
- Participant has received any investigational product or has had any procedure to the face within 4 weeks of the Screening Visit or is scheduled to receive an investigational product (other than the study product) or procedure to the face during the study.
- Participant has used systemic or other immunosuppressive medications within 4 weeks of the Screening Visit (inhaled corticosteroid less than or equal to 1000 microgram daily dose is acceptable).
- Participant is currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the participant at undue risk.
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Interventions
BTX1503 5% Solution, applied topically to the face using a supplied swab. Participants will receive a 1mL dose either once (QD) or twice daily (BD) on Day 1. Following a washout period, participants will receive a further 14 days of treatment starting on Day 8. Doses will be escalated for each subsequent cohort enrolled with the following doses: Cohort 1: 1 mL of BTX1503 5% Solution QD Cohort 2: 1 mL of BTX1503 5% Solution BID (12 hours apart) Cohort 3: 3 mL of BTX1503 5% Solution QD Cohort 4: 3 mL of BTX1503 5% Solution BID (12 hours apart) For participants receiving QD dosing, dosing will occur each day at the clinical site at the same time (+/-1 hour) in the morning (applied by clinical site staff). Participants receiving BID dosing will be instructed in how to apply study drug when not at the clinical site. For participants receiving BID dosing, the first application of study drug will occur at the study site on Day 8 in the morning and the second application will be self-administered by the participant 12 hours (+/-1 hour) later. Participants will come to the study site for their morning application of study drug and their evening application will be self-administered. For participants doing a self-administered application of study drug, a diary will be maintained documenting compliance with application of the self-administered application. Each dose of study drug will be applied to the entire face. Participants will be asked to apply the total amount of study drug per application evenly, as best as possible, to cover all the face. In addition, participants will be required to return all used and unused study drug at each visit where the study site will assess compliance.
Locations(1)
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ACTRN12617000642381