A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of Topical SM04755 Solution Following Topical Administration to Subjects with Mild to Moderate Plaque Psoriasis
- Conditions
- Plaque psoriasisSkin - Dermatological conditionsInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12617001178336
- Lead Sponsor
- Samumed Pacific Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 13
BMI of 18 to 40, inclusive
- Mild to moderate plaque psoriasis less than or equal to 10% body surface area
- A single, non-intertriginous lesion with target plaque area great than or equal to 30 and less than or equal to 60 cm2.
- Target Plaque Severity Score greater than or equal to 5 and less than or equal to 10 with Induration score greater than or equal to 2 and less than or equal to 4.
- Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon
- Subject must read and understand the informed consent form, and sign it prior to any study-related procedure being performed
- Willingness to comply with all scheduled study visits, laboratory tests, contraception requirements, and other study procedures
- Study cohort is open for randomization
- Women who are pregnant or lactating.
- Women of childbearing potential who are sexually active and are not willing to use birth control
- Males who are sexually active and not willing to use a condom
- History of allergy to investigational product/placebo ingredients
- Recent use of any topical treatment for plaque psoriasis
- Prior treatment with prescription medication for plaque psoriasis with no improvement in condition
- Prior treatment of plaque psoriasis with biologic therapies
- History of or current skin disease
- History of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic or dermatologic disease
- History of malignancy within the last 5 years
- Recent treatment with an investigational product
- History of cardiac arrhythmia
- Has current drug-induced psoriasis
- Excessive hair in the treatment area
- Unwilling to refrain from blood, plasma, platelet, or sperm donation
- Clinically significant laboratory abnormalities at Screening
- Clinically significant vital signs at Screening
- Active infection of hepatitis B or C or HIV
- Recent active infection or febrile illness
- Recent serious illness requiring hospitalization
- Positive urine drug screen result at Screening
- Previous treatment with SM04755
- Subjects who have a current or pending disability claim, workers’ compensation, or litigation(s)
- Subjects who are immediate family members of personnel directly affiliated with the study at any investigative site, or are directly affiliated with the study at any investigative site.
- Subjects employed by Samumed, LLC, or any of its affiliates or development partners responsible for the conduct of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method