A Randomized, Double-Blind, Vehicle-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Topically Applied INM-755 Cream in Healthy Volunteers
- Conditions
- Epidermolysis Bullosaspontaneaous blistering10014982
- Registration Number
- NL-OMON48156
- Lead Sponsor
- InMed Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
1. Male or female subject between 18 and 45 years of age inclusive at the time
of consent.
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
3. Subject is in good general health, according to the investigator*s judgment
based on vital signs, medical history, physical examination, and laboratory
tests performed.
4. Contraception:
a. Male participants:
i. A male participant who agrees to follow the contraceptive guidance during
their participation in this study from at least 4 weeks before Day 1 until at
least 4 weeks after the last study product administration. Effective
contraceptive methods are described in the protocol
b. Female participants:
i. A female participant is eligible to participate if she is not pregnant, does
not plan to become pregnant during the study, not breastfeeding, and at least 1
of the following conditions applies:
1. Not a woman of child-bearing potential (WOCBP)
OR
2. A WOCBP who agrees to follow the contraceptive guidance during their
participation in this study from at least 4 weeks before Day 1 until at least 4
weeks after the last study product administration. Effective contraceptive
methods are described in Section 4.5.1.
5. Female subject has had a negative urine pregnancy test at screening and at
Day 1 before dosing.
6. Subject is willing to participate and is capable of giving informed consent.
7. Subjects must be willing to comply with all study procedures, have the
ability to communicate well with the investigator in the Dutch language and
must be available for the duration of the study.
8. Subject has sufficient application area of healthy intact skin of the back.
A subject who meets any of the following criteria at screening and at Day 1
before dosing, unless specified otherwise, will be excluded from participation
in this study:
1. Subject is a female who is breastfeeding, pregnant, or who is planning to
become pregnant during the study.
2. Subject has a history of skin disease or presence of skin condition that, in
the opinion of the investigator, would interfere with the study assessments.
3. Subject has presence of or has a history of atopic dermatitis or psoriasis.
4. Any known allergy or hypersensitivity to medical adhesives (e.g., Tegaderm)
used in this study or any component of the study product (e.g. Poloxamers,
Lecithin, Isopropyl Palmitate).
5. Subject has presence of any tattoos, scratches, open sores, excessive hair,
or skin damages in the target treatment area(s) that, in the opinion of the
investigator, may interfere with study evaluations.
6. Subject has a Fitzpatrick*s Skin Phototype *4.
7. Subject is known to have immune deficiency or is immunocompromised.
8. Subject has a known history of chronic infectious disease (eg, hepatitis B,
hepatitis C, or infection with human immunodeficiency virus).
9. Subject has a history of cancer or lymphoproliferative disease within 5
years prior to Day 1. Subjects with successfully treated nonmetastatic
cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in
situ of the cervix are not to be excluded.
10. Subject had a major surgery within 8 weeks prior to Day 1 or has a major
surgery planned during the study.
11. Subject has any clinically significant medical condition or physical,
laboratory, ECG, or vital signs abnormality that would, in the opinion of the
investigator, put the subject at undue risk or interfere with interpretation of
study results.
12. Subject has used any systemic treatment that could be immunosuppressive
(including oral corticosteroids, oral retinoids, immunosuppressive medication,
methotrexate, cyclosporine, or apremilast) within 4 weeks prior to Day 1. Note:
Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear
drops containing corticosteroids are also allowed.
13. Subject has had excessive sun exposure, is planning a trip to a sunny
climate, or has used tanning booths within 4 weeks prior to Day 1 or is not
willing to minimize natural and artificial sunlight exposure during the study.
Use of sunscreen products (except on application areas) and protective apparel
are recommended when sun exposure cannot be avoided.
14. Subject has received laser treatment, electrolysis on the application areas
within 4 weeks prior to Day 1 or is planning to during the study period.
15. Subject has shaved the application area 72 hours prior to Day 1, or is
planning to do so during the study period.
16. Subject has used cannabis or any cannabinoid products within 12 weeks prior
to Day 1.
17. Subject has used any medication known to impair alertness and/or ability to
detect discomfort within 1 week prior to Day 1.
18. Subject has used a topical applied treatment on the targeted application
area(s) within 1 week prior to Day 1.
19. Subject has a known history of clinically significant drug or alcohol abuse
in the last year prior to Day 1.
20. Subject has a positive screen result for drug of abuse at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Tolerability / safety endpoints for Part 1 Objectives<br /><br>* Incidence of local and systemic treatment-emergent adverse events (TEAEs)<br /><br>* Changes in vital signs, ECG, safety laboratory tests, erythema, and local<br /><br>tolerability assessment<br /><br><br /><br>Pharmacokinetic endpoints for Part 1 Objectives<br /><br>* Measurement of plasma concentrations of INM-755.<br /><br>* Measurement of skin concentration of INM-755.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional endpoints for Part 1 Objectives<br /><br>* Change from baseline over time in Bond-Lader visual analogue scale (Mood<br /><br>Rating Scale) (BL-VAS) and Bowdle VAS (B-VAS)<br /><br><br /><br><br /><br>Wound Healing Endpoints for Part 2 Objective<br /><br>* Wound characteristics by LSCI, OCT, TEWL and 3D photographyand<br /><br>* Wound closure over time</p><br>