TendinopathyPhase 1NCT03229291
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
A Phase 1 study testing SM04755 in people with Tendinopathy, run by Biosplice Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- SM04755
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2016to 11 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Tendinopathy
- Being tested
- SM04755, Vehicle
- Keywords
- SM04755, topical, Samumed, Wnt inhibitor
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM04755Drug
SM04755 is a small molecule inhibitor of the Wnt pathway.
VehicleDrug
Same formulation as topical SM04755 solution, without SM04755 included.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Topical SM04755 solution (15 mg/mL) applied once per day for 14 days Receives: Drug: SM04755 |
| Mid Dose | Experimental | Topical SM04755 solution (45 mg/mL) applied once per day for 14 days Receives: Drug: SM04755 |
| High Dose | Experimental | Topical SM04755 solution (90 mg/mL) applied once per day for 14 days Receives: Drug: SM04755 |
| Vehicle | Placebo comparator | Vehicle solution applied once per day for 14 days Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence and severity of AEs events during the treatment and observation periods of the study
Measured: Day 28
Incidence of clinical laboratory abnormalities
Incidence and severity of clinical laboratory measurements that are outside the normal range
Measured: Day 28
Change in vital signs: blood pressure
Change from baseline in blood pressure
Measured: Baseline and Day 28
Change in vital signs: temperature
Change from baseline in temperature
Measured: Baseline and Day 28
Change in vital signs: respiratory rate
Change from baseline in respiratory rate
Measured: Baseline and Day 28
Change in vital signs: pulse rate
Change from baseline in pulse rate
Measured: Baseline and Day 28
Change in electrocardiogram (ECG) parameters
Change from baseline in 12-lead ECG parameters
Measured: Baseline and Day 28
Plasma pharmacokinetics (PK): Cmax
Maximum plasma concentration (Cmax) estimate for SM04755 following first dose
Measured: Day 1
Plasma pharmacokinetics (PK):tmax
Time to Cmax estimate for SM04755 following first dose
Measured: Day 1
Plasma pharmacokinetics (PK): AUC
Area under the plasma concentration-time curve (AUC) estimate for SM04755 following first dose
Measured: Day 1
Plasma pharmacokinetics (PK):half-life
Plasma terminal phase half-life estimate for SM04755 following first dose
Measured: Day 1
Plasma pharmacokinetics (PK):Cmax
Maximum plasma concentration (Cmax) estimate for SM04755 following last dose
Measured: Day 14
Plasma pharmacokinetics (PK):tmax
Time to Cmax estimate for SM04755 following last dose
Measured: Day 14
Plasma pharmacokinetics (PK): AUC
AUC estimate for SM04755 following last dose
Measured: Day 14
Plasma pharmacokinetics (PK):half-life
Plasma terminal phase half-life estimate for SM04755 following last dose
Measured: Day 14
Change in skin score assessment: erythema
Change from baseline in erythema skin score assessment
Measured: Baseline and Day 28
Change in skin score assessment: scaling
Change from baseline in scaling skin score assessment
Measured: Baseline and Day 28
Change in skin score assessment: pruritus/itching
Change from baseline in pruritus/itching skin score assessment
Measured: Baseline and Day 28
Change in skin score assessment: burning/stinging
Change from baseline in burning/stinging skin score assessment
Measured: Baseline and Day 28
Secondary outcomes (1)
Incidence of AEs relative to exposure
Incidence and severity of AEs relative to measured plasma exposure to SM04755
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start3 Nov 2016
- Primary completion11 Jun 2017
- Study completion11 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusuf Yazici, M.D., Study director, Biosplice Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229291
- Sponsor's protocol ID
- SM04755-TOP-01
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03229291
- Acronym / sponsor ID
- SM04755-TOP-01
- Conditions
- Tendinopathy
- Keywords
- SM04755, topical, Samumed, Wnt inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 11 Jun 2017 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: SM04755Topical SM04755 solution (15 mg/mL) applied once per day for 14 days |
| Mid Dose | Experimental | Drug: SM04755Topical SM04755 solution (45 mg/mL) applied once per day for 14 days |
| High Dose | Experimental | Drug: SM04755Topical SM04755 solution (90 mg/mL) applied once per day for 14 days |
| Vehicle | Placebo comparator | Drug: VehicleVehicle solution applied once per day for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM04755SM04755 is a small molecule inhibitor of the Wnt pathway. | Drug | High Dose, Low Dose, Mid Dose |
| VehicleSame formulation as topical SM04755 solution, without SM04755 included. | Drug | Vehicle |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Day 28
Incidence and severity of AEs events during the treatment and observation periods of the study
Incidence of clinical laboratory abnormalities
Time frame: Day 28
Incidence and severity of clinical laboratory measurements that are outside the normal range
Change in vital signs: blood pressure
Time frame: Baseline and Day 28
Change from baseline in blood pressure
Change in vital signs: temperature
Time frame: Baseline and Day 28
Change from baseline in temperature
Change in vital signs: respiratory rate
Time frame: Baseline and Day 28
Change from baseline in respiratory rate
Change in vital signs: pulse rate
Time frame: Baseline and Day 28
Change from baseline in pulse rate
Change in electrocardiogram (ECG) parameters
Time frame: Baseline and Day 28
Change from baseline in 12-lead ECG parameters
Plasma pharmacokinetics (PK): Cmax
Time frame: Day 1
Maximum plasma concentration (Cmax) estimate for SM04755 following first dose
Plasma pharmacokinetics (PK):tmax
Time frame: Day 1
Time to Cmax estimate for SM04755 following first dose
Plasma pharmacokinetics (PK): AUC
Time frame: Day 1
Area under the plasma concentration-time curve (AUC) estimate for SM04755 following first dose
Plasma pharmacokinetics (PK):half-life
Time frame: Day 1
Plasma terminal phase half-life estimate for SM04755 following first dose
Plasma pharmacokinetics (PK):Cmax
Time frame: Day 14
Maximum plasma concentration (Cmax) estimate for SM04755 following last dose
Plasma pharmacokinetics (PK):tmax
Time frame: Day 14
Time to Cmax estimate for SM04755 following last dose
Plasma pharmacokinetics (PK): AUC
Time frame: Day 14
AUC estimate for SM04755 following last dose
Plasma pharmacokinetics (PK):half-life
Time frame: Day 14
Plasma terminal phase half-life estimate for SM04755 following last dose
Change in skin score assessment: erythema
Time frame: Baseline and Day 28
Change from baseline in erythema skin score assessment
Change in skin score assessment: scaling
Time frame: Baseline and Day 28
Change from baseline in scaling skin score assessment
Change in skin score assessment: pruritus/itching
Time frame: Baseline and Day 28
Change from baseline in pruritus/itching skin score assessment
Change in skin score assessment: burning/stinging
Time frame: Baseline and Day 28
Change from baseline in burning/stinging skin score assessment
1 secondary outcome
Incidence of AEs relative to exposure
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Yazici, M.D. study director
Biosplice Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SM04755 in people with Tendinopathy, run by Biosplice Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Day 28). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.