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A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03229291
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Brief Summary:
This study is a single-center, randomized, single-blind, placebo-controlled, multiple ascending dose study of SM04755 solution applied topically once daily for 14 days to intact skin overlying the inner thigh of healthy subjects at an estimated body surface area (BSA) of 80 cm^2. Dosing cohorts will consist of 8 subjects who will be randomized 3:1 (SM04755:placebo).

Condition or disease Intervention/treatment Phase
Tendinopathy Drug: SM04755 Drug: Vehicle Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Center, Randomized, Single-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : June 11, 2017
Actual Study Completion Date : June 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: Low Dose
Topical SM04755 solution (15 mg/mL) applied once per day for 14 days
Drug: SM04755
SM04755 is a small molecule inhibitor of the Wnt pathway.

Experimental: Mid Dose
Topical SM04755 solution (45 mg/mL) applied once per day for 14 days
Drug: SM04755
SM04755 is a small molecule inhibitor of the Wnt pathway.

Experimental: High Dose
Topical SM04755 solution (90 mg/mL) applied once per day for 14 days
Drug: SM04755
SM04755 is a small molecule inhibitor of the Wnt pathway.

Placebo Comparator: Vehicle
Vehicle solution applied once per day for 14 days
Drug: Vehicle
Same formulation as topical SM04755 solution, without SM04755 included.




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Day 28 ]
    Incidence and severity of AEs events during the treatment and observation periods of the study

  2. Incidence of clinical laboratory abnormalities [ Time Frame: Day 28 ]
    Incidence and severity of clinical laboratory measurements that are outside the normal range

  3. Change in vital signs: blood pressure [ Time Frame: Baseline and Day 28 ]
    Change from baseline in blood pressure

  4. Change in vital signs: temperature [ Time Frame: Baseline and Day 28 ]
    Change from baseline in temperature

  5. Change in vital signs: respiratory rate [ Time Frame: Baseline and Day 28 ]
    Change from baseline in respiratory rate

  6. Change in vital signs: pulse rate [ Time Frame: Baseline and Day 28 ]
    Change from baseline in pulse rate

  7. Change in electrocardiogram (ECG) parameters [ Time Frame: Baseline and Day 28 ]
    Change from baseline in 12-lead ECG parameters

  8. Plasma pharmacokinetics (PK): Cmax [ Time Frame: Day 1 ]
    Maximum plasma concentration (Cmax) estimate for SM04755 following first dose

  9. Plasma pharmacokinetics (PK):tmax [ Time Frame: Day 1 ]
    Time to Cmax estimate for SM04755 following first dose

  10. Plasma pharmacokinetics (PK): AUC [ Time Frame: Day 1 ]
    Area under the plasma concentration-time curve (AUC) estimate for SM04755 following first dose

  11. Plasma pharmacokinetics (PK):half-life [ Time Frame: Day 1 ]
    Plasma terminal phase half-life estimate for SM04755 following first dose

  12. Plasma pharmacokinetics (PK):Cmax [ Time Frame: Day 14 ]
    Maximum plasma concentration (Cmax) estimate for SM04755 following last dose

  13. Plasma pharmacokinetics (PK):tmax [ Time Frame: Day 14 ]
    Time to Cmax estimate for SM04755 following last dose

  14. Plasma pharmacokinetics (PK): AUC [ Time Frame: Day 14 ]
    AUC estimate for SM04755 following last dose

  15. Plasma pharmacokinetics (PK):half-life [ Time Frame: Day 14 ]
    Plasma terminal phase half-life estimate for SM04755 following last dose

  16. Change in skin score assessment: erythema [ Time Frame: Baseline and Day 28 ]
    Change from baseline in erythema skin score assessment

  17. Change in skin score assessment: scaling [ Time Frame: Baseline and Day 28 ]
    Change from baseline in scaling skin score assessment

  18. Change in skin score assessment: pruritus/itching [ Time Frame: Baseline and Day 28 ]
    Change from baseline in pruritus/itching skin score assessment

  19. Change in skin score assessment: burning/stinging [ Time Frame: Baseline and Day 28 ]
    Change from baseline in burning/stinging skin score assessment


Secondary Outcome Measures :
  1. Incidence of AEs relative to exposure [ Time Frame: Day 28 ]
    Incidence and severity of AEs relative to measured plasma exposure to SM04755



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229291


Locations
United States, Arizona
Research Site
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Samumed LLC
Investigators
Study Director: Yusuf Yazici, M.D. Samumed LLC

Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT03229291     History of Changes
Other Study ID Numbers: SM04755-TOP-01
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samumed LLC:
SM04755
topical
Samumed
Wnt inhibitor

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries