A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty

• ClinicalTrials.gov Identifier: NCT05422378
• Recruitment Status: Active, not recruiting
• First Posted: June 16, 2022
• Last Update Posted: March 1, 2023
• Sponsor: Sirnaomics
• Information provided by (Responsible Party): Sirnaomics

Study Description

Brief Summary:

Dose-ranging, randomized, double-blind, vehicle-controlled study

Condition or disease	Intervention/treatment	Phase
Abdominal Obesity	Drug: STP705	Phase 1

Detailed Description:

Subject will receive a single injection for each treatment which all 3 test article concentrations and both injection volumes and the vehicle for a total of 7 treatments.

Subjects will receive test articles in 3 visits.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Dose-ranging, double-blind, vehicle-controlled
• Masking: Double (Participant, Investigator)
• Masking Description: double-blind (investigator & subjects)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty
• Actual Study Start Date: August 1, 2022
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: STP705, 120ug/mL, 0.5 cc; Volume of Injection 0.5cc	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
Experimental: STP705, 120ug/mL, 1.0 cc; Volume of Injection 1.0cc	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
Experimental: STP705, 240 ug/mL, 0.5 cc; Volume of Injection 0.5cc	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
Experimental: STP705, 240ug/mL, 1.0 cc; Volume of Injection 1.0cc	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
Experimental: STP705, 320ug/mL, 0.5 cc; Volume of Injection 0.5cc	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
Experimental: STP705, 320ug/mL, 1.0 cc; Volume of Injection 1.0cc	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.
Placebo Comparator: Vehicle; 1.0cc placebo	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.

Outcome Measures

Primary Outcome Measures :

1. Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising. [ Time Frame: 24 weeks ]
   LSR scale will be used by investigator to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, limited involvement, 2= moderate involvement, and 3= severe, extreme involvement)
2. Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning. [ Time Frame: 24 weeks ]
   LSR scale will be used by subjects to assess injection site using a 4-point ordinal scale (0=complete absence, 1=mild, 2= moderate, and 3= severe)
3. Incidence (severity and causality) of any AEs [ Time Frame: 24 weeks ]
   AE's will be classified using CTCAE v.5.0

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

To enter the study, a subject must meet the following criteria:

1. Subject is a male or non-pregnant female 18-65 years of age.
2. Subject has provided written informed consent.
3. Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 3/Baseline.
4. Subject has agreed to undergo an abdominoplasty procedure, participate in this study, has minimally acceptable adipose tissue in the target areas per protocol, and meets all pre-operative requirements, in the opinion of the investigator and surgeon.

Exclusion Criteria:

A subject is ineligible to enter the study if he/she meets one or more of the following criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has a significant active systemic or localized abdominal infection.
3. Subject has a body mass index (BMI) ≥40.
4. Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
5. Subject is taking any medications that affect clotting and/or platelet function. This includes, but is not limited to, heparin (including low molecular weight heparin), Coumadin, and factor Xa agents such as apixaban (Eliquis), etc. The use of such medications is precluded up to 7 days prior to Visit 3/Baseline and during the study period.
6. Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., HIV positive, malignancy), medication use, or other factors.
7. Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism or excretion.
8. Subject has local skin condition(s) (e.g., rash, scarring, and tattoos) or inadequate injection sites in the region designated for abdominoplasty excision which are inappropriate for participation in the study, in the opinion of the investigator.
9. Subject is currently enrolled in an investigational drug, biologic, or device study.
10. Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to first injection of the test article.
11. Subject has a history of sensitivity to any of the ingredients in the test articles (see Section 6.1).
12. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Contacts and Locations

Locations

United States, Florida

Center for Clinical and Cosmetic Research

Aventura, Florida, United States, 33180

Sponsors and Collaborators

Sirnaomics

More Information

• Responsible Party: Sirnaomics
• ClinicalTrials.gov Identifier: NCT05422378
• Other Study ID Numbers: SRN-705-010
• First Posted: June 16, 2022
• Last Update Posted: March 1, 2023
• Last Verified: April 2022

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

Additional relevant MeSH terms:

Obesity, Abdominal; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight