A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers

NCT03502434 | Completed Phase 1 FDA Drug

• 1 other identifier: SM04755-TOP-02
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, controlled, within subject comparison, single dose study to determine the sensitization potential of SM04755 solution on normal skin under semi-occlusive patch conditions.

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (3)

• Contact sensitization potential of Test Material as measured by Treatment emergent

  Baseline to Day 40 (or through the observation period for TEAEs)

• Contact sensitization potential of Test Material as measured by Reaction Grade

  Reaction Grade is measured on a 5-point scale from zero to four (zero = no sign of irritation and 4 = Erythema with edema and blistering)

  Baseline to Day 38-40

• Contact sensitization potential of Test Material as measured by Investigator assessment of irritation and sensitization

  Baseline to Day 40

Study Arms (6)

90 mg/mL SM04755 in water

EXPERIMENTAL

90 mg/mL SM04755 in water applied via patches

Drug: SM04755

90 mg/mL SM04755 in aqueous Vehicle

EXPERIMENTAL

90 mg/mL SM04755 in aqueous Vehicle applied via patches

Drug: SM04755

90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol)

EXPERIMENTAL

90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol) applied via patches

Drug: SM04755

Vehicle

OTHER

Aqueous Vehicle applied via patches

Other: Vehicle

White petrolatum

OTHER

White petrolatum (Negative control) applied via patches

Other: White Petrolatum

Sodium lauryl sulfate

OTHER

Sodium lauryl sulfate (SLS 0.5%) (Positive control) applied via patches

Other: Sodium lauryl sulfate

Interventions

SM04755 DRUG

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

90 mg/mL SM04755 in aqueous Vehicle; 90 mg/mL SM04755 in aqueous Vehicle (without Benzyl Alcohol); 90 mg/mL SM04755 in water

Vehicle OTHER

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

Vehicle

White Petrolatum OTHER

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

White petrolatum

Sodium lauryl sulfate OTHER

Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.

Sodium lauryl sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult males and females at least 18 years of age
• Subjects of any Fitzpatrick skin type or race provided their degree of skin pigmentation does not, in the Investigator or designee's opinion, interfere with study assessments
• Subject has no signs of irritation (i.e., a Reaction Grade of "0") at patch application sites on the back prior to the initial patch application on Day 1
• Subject must have read, understood, and signed the informed consent form prior to any study-related procedure being performed
• Subject is willing and able to comply with all scheduled study visits, urine pregnancy tests (if applicable), contraception requirements (male and female), and other study requirements
• Subject is willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study

You may not qualify if:

• 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, IUD, or hormonal contraceptive combined with single barrier, or abstinence
• Women of childbearing potential who have had unprotected sexual intercourse within 30 days prior to Day 1
• 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)
• Subject has any skin condition that, in the Investigator's opinion, could interfere with the study assessments or put the subject at undue risk by study participation
• Subject has severe atopic dermatitis/eczema, psoriasis or chronic asthma
• Subject has tattoos, excessive hair, moles, scarring, etc. which would interfere with patching
• Subject has a history of sensitivity to any component of any of the Test Materials
• Use of any of the following medications:
• Systemic or topical glucocorticoids within 4 weeks prior to Day 1
• Systemic or topical analgesics (e.g., NSAIDs, high dose aspirin, etc.) within 1 week prior to Day 1. Note: Daily use of ≤325 mg of aspirin for cardiovascular disease or prophylaxis is allowed. Maximum daily use of Tylenol ≤3000 mg is allowed.
• Antihistamines within 1 week prior to Day 1. Note: H2 blockers such as Pepcid, Zantac, and Tagamet are permitted.
• Anti-inflammatories within 1 week prior to Day 1
• Immunosuppressant medications (e.g., TNF-alpha inhibitors, topical tacrolimus, etc.) within 4 weeks prior to Day 1 (or within 6 half-lives prior to Day 1 for biologics)
• Subject has had previous treatment with SM04755

Sponsors & Collaborators

• Biosplice Therapeutics, Inc.: lead

Study Sites (1)

Research Site

Lynchburg, Virginia, 24503, United States

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Petrolatum; Sodium Dodecyl Sulfate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals; Dodecanol; Fatty Alcohols; Alcohols; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Study Officials

• Yusuf Yazici, M.D.

  Biosplice Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Principal Investigator, subjects, and the site personnel who will be performing Reaction Grade assessments will be blinded to the Test Material identity, with the exception of the Positive Control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 18, 2018
• Study Start: September 11, 2017
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)