An interventional study to evaluate the effect and safety of PRN473 topical on skin reactions of otherwise healthy participants with allergies to common allergens.
A Phase I, Open-Label, Placebo-Controlled, Challenge Study to Evaluate the Pharmacologic Activity of Topically Administered PRN473 on the Skin Reaction Induced by Challenge Agents via a Skin Prick in Participants with Immunoglobulin E-Mediated Allergies
Principia Biopharma Inc.
24 participants
Jun 25, 2020
Interventional
Conditions
Summary
This research project is being conducted to look at the effect and safety of PRN473 topical on skin reactions of otherwise healthy participants with allergies to 2 common allergens - when PRN473 topical is applied to the skin both prior to and following a skin prick with 2 of the allergens.
Eligibility
Inclusion Criteria4
- Adult males or women who are surgically sterile or postmenopausal, 18 to 55 years of age and can provide written informed consent;
- Medical history of Type 1 allergies, including rhinitis, asthma, or eczema, or history of asymptomatic skin sensitization following SPTs in the last 2 years;
- Positive response (greater than or equal to 3 mm of wheal diameter greater than saline control) to 2 common allergens following a skin prick test;
- If male, agrees to use acceptable contraception.
Exclusion Criteria7
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV);
- History or presence of alcoholism or drug abuse;
- History of any significant (as determined by the investigator) drug-related allergic reactions such as, hypersensitivity, anaphylaxis, Stevens-Johnson syndrome;
- Excessive sun exposure, phototherapy or use of a tanning salon from within 2 weeks prior to Day 1 until the end of study (EOS) visit
- Clinically significant medical history, of chronic or acute disease or infection
- Use of any oral or topical medication with anti-inflammatory or antihistamine activity or sleep aids within 7 days prior to Day 1 and through end of the study.
- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days prior Day 1 or 5 half-lives, whichever is longer
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Interventions
Screening The first skin prick test will be conducted at screening day. Allergen solutions containing one of the following: cat hair, dust mite and ryegrass will be applied to the forearm at Screening via a Skin Prick Test by a nurse and the response will be measured at 15 minutes. Individual participant responsiveness to the three allergens will be confirmed by comparing each allergen response to the positive (histamine) and negative (saline) controls. Day 1 Eligible participants that respond to two allergens at screening will enroll and attend a Day 1 visit. The two allergens that elicit the greatest wheal response for each participant will be applied to the skin on the participants’ back via Skin Prick Test. Treatment The upper back of eligible participants will be divided into left and right zones. The left zone will be used for prophylactic purpose with treatments (placebo and PRN473 treatments) applied 2 hours prior to skin prick and the right zone will be used for therapeutic purpose (placebo and PRN473 treatments) applied 5 minutes after the skin prick. Each zone will be divided into 6 microzones of approximately 14cm squared surface area as below. Left Zone-Prophylaxis Microzones-Two skin pricks per microzone L-MZ#1 positive histamine control and negative saline control L-MZ#2 Allergen #1 and Allergen #2 without treatment L-MZ#3 Allergen #1 and Allergen #2 with placebo topical applied 2 hour prior to skin prick L-MZ#4 Allergen #1 and Allergen #2 with PRN473 5 % topical applied 2 hour prior to skin prick L-MZ#5 Allergen #1 and Allergen #2 with PRN473 2 % topical applied 2 hour prior to skin prick L-MZ#6 Allergen #1 and Allergen #2 with PRN473 0.5 % topical applied 2 hour prior to skin prick Right Zone-Therapeutic Microzones-Two skin prick per microzone R-MZ#1 positive histamine control and negative saline control R-MZ #2 Allergen #1 and Allergen #2 without treatment R-MZ #3 Allergen #1 and Allergen #2 with placebo topical applied 5 minutes after skin prick R-MZ #4 Allergen #1 and Allergen #2 with PRN473 5 % topical applied 5 minutes after skin prick R-MZ #5 Allergen #1 and Allergen #2 with PRN473 2 % topical applied 5 minutes after skin prick R-MZ #6 Allergen #1 and Allergen #2 with PRN473 0.5 % topical applied 5 minutes after skin prick On day 1, skin assessment after each test will be conducted up to 60 minutes and the same allergens will be used on both prophylactic and therapeutic zones. Dose Placebo and three strengths of PRN473 topical (0.5%, 2%, and 5%) will be applied topically in parallel to the backs of each participant in designated microzones. For each strength, approximately 250 mg of topical product applied over 14 cm squared microzone area as the starting amount in the first few subject. The amount applied may be increased up to 750mg per 14cm squared microzone area for future subjects, based on the ability of treatment to prevent skin reaction. The study team will analyze the observed wheal and erythema assessments on Day 1. For each participant the amount of applied treatment will be predetermined before Day 1 application. The same amount of treatment will be applied for prophylactic (left) and therapeutic (right) zones. No dose adjustment will be made after application of treatments on Day 1. All Skin Prick Tests, as well as PRN473 treatments and placebo will be administered by nurse. The responses to allergens are measured by a nurse for 60 minutes after Skin Prick Test and validated by another nurse. Procedures, including dose application, skin prick test administration and outcome measures will be fully documented by site staff, and overseen by an observing study team member. An application grid (per site procedures) will be used to ensure treatments are applied within the applicable microzones. Routine quality review will occur to assess logistical compliance to protocol requirements.
Locations(1)
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ACTRN12620000693921