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

Abdominal Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422378
• Other study ID #: SRN-705-010
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2022
• Est. completion date: June 27, 2023

Study information

• Verified date: March 2024
• Source: Sirnaomics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 27, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

Drug:
• STP705
STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually.

Locations

Country	Name	City	State
United States	Center for Clinical and Cosmetic Research	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sirnaomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence (severity and causality) of any AEs	AE's will be classified using CTCAE v.5.0	24 weeks