A Randomized, Double-Blind, Vehicle-Controlled, Sample Size Adaptive Design Study to Evaluate the Safety and Efficacy of Topically Applied EB01 Cream in Healthy Adult Volunteers and Adult Subjects with Moderate to Severe Chronic Allergic Contact Dermatitis

∙ All subjects:

• Men and women ≥ 18 years old, inclusive, at the time of consent.

• For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use an effective contraceptive method from at least 4 weeks before Day 1 until at least 4 weeks after the last study product application. Effective contraceptive methods include hormonal contraceptives (combined oral contraceptive, patch, vaginal ring, injectable, or implant), intrauterine devices or intrauterine systems, vasectomized partner(s), tubal ligation, or a barrier method of contraception (male condom, female condom, cervical cap, diaphragm, contraceptive sponge) in conjunction with spermicide.

• Note: Subjects must have been on a stable dose of hormonal contraceptives for at least 4 weeks before Day 1.

• Note: The above list of contraceptive methods does not apply to subjects who are abstinent for at least 4 weeks before Day 1 and will continue to be abstinent from penile-vaginal intercourse throughout the study. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.

• Note: A woman of nonchildbearing potential is as follows:

‣ Woman who has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy);

‣ Woman who has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels).

• For men involved in any sexual intercourse that could lead to pregnancy, subject must agree to use one of the effective contraceptive methods listed in Inclusion Criterion #2 from Day 1 until at least 4 weeks after the last study product application. If the female partner of a male subject use any of the hormonal contraceptive methods listed above, this contraceptive method must be used by the female partner from at least 4 weeks before Day 1 until at least 4 weeks after the last study product application.

• Female of childbearing potential has had a negative pregnancy test at screening visit.

• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.

• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

∙ HV only:

• Subject is in good general health, according to the investigator's judgment based on medical history and physical examination/laboratory/ECG/vital signs assessments.

∙ Subjects with allergic contact dermatitis only:

• Subject has at least 3-month history of allergic contact dermatitis (information obtained from medical chart or subject's physician, or directly from the subject).

• Subject has moderate to severe chronic allergic contact dermatitis at Day 1, defined by either one of the following:

‣ CDSI score ≥ 7

⁃ CDSI score of severe (3) in ≥ 2 of the 5 assessed symptoms (Fissures, Scaling, Redness, Pruritus, Dryness)

• Subject has allergic contact dermatitis covering between 0.5% to 10% of the total BSA at Day 1.

• Subject has an ISGA ≥ 3 at Day 1.

• The subject has had a positive patch test (+, ++ or +++ reaction) to an allergen that is suspected to be involved in the current allergic contact dermatitis in the past 5 years (obtain written documentation of patch test result if possible).

• Alternatively, the Subject agrees to undergo patch testing during the study period (patch testing needs to be completed by Day 36). Guidelines for patch test interpretation are provided in Appendix 2. The measure of the degree of the reaction will be determined on the basis of the reading 2 and 3-4 days post application.

• Subject agrees to only apply personal care products (i.e. makeup and eyeshadow) that do not contain their allergen(s) on lesions only after applying the IP.

• Subject agrees not to apply any personal care products on allergic contact dermatitis lesions prior to site visits.

∙ Subjects with allergic contact dermatitis in the Open Label Extension:

• Subject has completed the main study.