A Study Evaluating the Safety, Tolerability, and Pharmaco... | NCT03229291

Status Module

Label	Type	Description	Intervention Names
Low Dose	Experimental	Topical SM04755 solution (15 mg/mL) applied once per day for 14 days	Drug: SM04755
Mid Dose	Experimental	Topical SM04755 solution (45 mg/mL) applied once per day for 14 days	Drug: SM04755
High Dose	Experimental	Topical SM04755 solution (90 mg/mL) applied once per day for 14 days	Drug: SM04755
Vehicle	Placebo Comparator	Vehicle solution applied once per day for 14 days	Drug: Vehicle

Name	Type	Description	Arm Group Labels	Other Names
SM04755	Drug	SM04755 is a small molecule inhibitor of the Wnt pathway.	High Dose Low Dose Mid Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)	Incidence and severity of AEs events during the treatment and observation periods of the study	Day 28
Incidence of clinical laboratory abnormalities	Incidence and severity of clinical laboratory measurements that are outside the normal range	Day 28
Change in vital signs: blood pressure	Change from baseline in blood pressure	Baseline and Day 28
Change in vital signs: temperature	Change from baseline in temperature	Baseline and Day 28
Change in vital signs: respiratory rate	Change from baseline in respiratory rate	Baseline and Day 28
Change in vital signs: pulse rate	Change from baseline in pulse rate	Baseline and Day 28
Change in electrocardiogram (ECG) parameters	Change from baseline in 12-lead ECG parameters	Baseline and Day 28
Plasma pharmacokinetics (PK): Cmax	Maximum plasma concentration (Cmax) estimate for SM04755 following first dose

Measure	Description	Time Frame
Incidence of AEs relative to exposure	Incidence and severity of AEs relative to measured plasma exposure to SM04755	Day 28

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Body mass index of 18 to 30 kg/m^2 at study start
Subject must have read and understood the informed consent form, and must have signed 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
Appropriate skin characteristics at site of application (inner thigh) (for example, consistent pigmentation, no tattoos, no scarring or noted injury, no varicose veins or structural repair)
Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study

Exclusion Criteria:

Women who are pregnant or lactating
Women of childbearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period that includes double barrier, intrauterine device (IUD), or hormonal contraceptive combined with single barrier, or abstinence
Males who are sexually active and not willing to use a condom, and have a partner who is capable of becoming pregnant, if neither has had surgery to become sterilized, and/or who are not willing to use double barrier or whose partner is not using a highly effective method of birth control (e.g., IUD or hormonal contraception combined with single barrier).
History of, or current, skin disease (for example, psoriasis, atopic dermatitis, seborrheic dermatitis, and skin cancer)
History of, or current, skin damage at the treatment site (inner thigh) (for example, cuts, abrasion, sunburn, sun-damage, or scarring)
Phototherapy or use of a tanning salon 2 weeks prior to study start until end of the study (Day 28)
History of, or current, allergy to investigational product/placebo ingredients
Known allergy to adhesive tape
Current evidence of malignancy or history of malignancy within the last 5 years prior to study start; prior history of in situ cancer or basal or squamous cell skin cancer, completely excised, is allowed
Treatment with an investigational product within 12 weeks prior to study start; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to study start
Use of any prescription or nonprescription drugs [except birth control or hormone replacement therapy (HRT)], topical skin treatments on the application site (inner thigh), vitamins, grapefruit/grapefruit juice, or dietary or herbal supplements within 14 days prior to study start
Blood donation of ≥ 1 pint (473 mL) within 56 days prior to study start or unwilling to refrain from blood donation for the duration of the study
Plasma or platelet donation within 14 days prior to study start or unwilling to refrain from plasma or platelet donation for the duration of the study
Unwilling to refrain from sperm donation for the duration of the study and until 90 days after dose administration
Prior or current latent or active tuberculosis (TB) or nontuberculous mycobacteria infection.
Evidence of active infection or illness involving fever within 7 days prior to study start
Occurrence of serious illness requiring hospitalization within 6 months prior to study start
Regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months prior to study start
Use of tobacco- or nicotine-containing products (cigarettes, pipe, cigar, chewing tobacco or nicotine gum, lozenges or patches) within 30 days prior to study start
A history of abuse of prescription or illicit drugs within 6 months prior to study start
Marijuana use within 28 days prior to study start
Previous treatment with SM04755
Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D013708	Tendon Injuries
D014947	Wounds and Injuries