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

A Phase 1 Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty

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

Study Overview

• Status: Completed
• Conditions: Abdominal Obesity
• Intervention / Treatment: Drug: STP705

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / 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.; Other Names: STP705 Powder for Injection
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.; Other Names: STP705 Powder for Injection
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.; Other Names: STP705 Powder for Injection
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.; Other Names: STP705 Powder for Injection
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.; Other Names: STP705 Powder for Injection
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.; Other Names: STP705 Powder for Injection
Placebo Comparator: Vehicle; 1.0cc placebo	Drug: STP705; STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.; Other Names: STP705 Powder for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.	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)	24 weeks
Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning.	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)	24 weeks
Incidence (severity and causality) of any AEs	AE's will be classified using CTCAE v.5.0	24 weeks

Collaborators and Investigators

• Sponsor: Sirnaomics
• Investigators: Principal Investigator: Mark Nestor, MD, Center for Clinical and Cosmetic Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: SRN-705-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No