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

July 21, 2017 updated by: Biosplice Therapeutics, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: Day 28
Incidence and severity of AEs events during the treatment and observation periods of the study
Day 28
Incidence of clinical laboratory abnormalities
Time Frame: Day 28
Incidence and severity of clinical laboratory measurements that are outside the normal range
Day 28
Change in vital signs: blood pressure
Time Frame: Baseline and Day 28
Change from baseline in blood pressure
Baseline and Day 28
Change in vital signs: temperature
Time Frame: Baseline and Day 28
Change from baseline in temperature
Baseline and Day 28
Change in vital signs: respiratory rate
Time Frame: Baseline and Day 28
Change from baseline in respiratory rate
Baseline and Day 28
Change in vital signs: pulse rate
Time Frame: Baseline and Day 28
Change from baseline in pulse rate
Baseline and Day 28
Change in electrocardiogram (ECG) parameters
Time Frame: Baseline and Day 28
Change from baseline in 12-lead ECG parameters
Baseline and Day 28
Plasma pharmacokinetics (PK): Cmax
Time Frame: Day 1
Maximum plasma concentration (Cmax) estimate for SM04755 following first dose
Day 1
Plasma pharmacokinetics (PK):tmax
Time Frame: Day 1
Time to Cmax estimate for SM04755 following first dose
Day 1
Plasma pharmacokinetics (PK): AUC
Time Frame: Day 1
Area under the plasma concentration-time curve (AUC) estimate for SM04755 following first dose
Day 1
Plasma pharmacokinetics (PK):half-life
Time Frame: Day 1
Plasma terminal phase half-life estimate for SM04755 following first dose
Day 1
Plasma pharmacokinetics (PK):Cmax
Time Frame: Day 14
Maximum plasma concentration (Cmax) estimate for SM04755 following last dose
Day 14
Plasma pharmacokinetics (PK):tmax
Time Frame: Day 14
Time to Cmax estimate for SM04755 following last dose
Day 14
Plasma pharmacokinetics (PK): AUC
Time Frame: Day 14
AUC estimate for SM04755 following last dose
Day 14
Plasma pharmacokinetics (PK):half-life
Time Frame: Day 14
Plasma terminal phase half-life estimate for SM04755 following last dose
Day 14
Change in skin score assessment: erythema
Time Frame: Baseline and Day 28
Change from baseline in erythema skin score assessment
Baseline and Day 28
Change in skin score assessment: scaling
Time Frame: Baseline and Day 28
Change from baseline in scaling skin score assessment
Baseline and Day 28
Change in skin score assessment: pruritus/itching
Time Frame: Baseline and Day 28
Change from baseline in pruritus/itching skin score assessment
Baseline and Day 28
Change in skin score assessment: burning/stinging
Time Frame: Baseline and Day 28
Change from baseline in burning/stinging skin score assessment
Baseline and Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of AEs relative to exposure
Time Frame: Day 28
Incidence and severity of AEs relative to measured plasma exposure to SM04755
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosplice Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SM04755-TOP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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