Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Dose-ranging, randomized, double-blind, vehicle-controlled study
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STP705, 120ug/mL, 0.5 cc | Experimental | Volume of Injection 0.5cc |
|
| STP705, 120ug/mL, 1.0 cc | Experimental | Volume of Injection 1.0cc |
|
| STP705, 240 ug/mL, 0.5 cc | Experimental | Volume of Injection 0.5cc |
|
| STP705, 240ug/mL, 1.0 cc | Experimental | Volume of Injection 1.0cc |
|
| STP705, 320ug/mL, 0.5 cc | Experimental | Volume of Injection 0.5cc |
|
| STP705, 320ug/mL, 1.0 cc | Experimental | Volume of Injection 1.0cc |
|
| Vehicle |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STP705 | Drug | STP705 composed of 2 siRNA targeting TGF-B1and COX-2 individually. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
To enter the study, a subject must meet the following criteria:
Exclusion Criteria:
A subject is ineligible to enter the study if he/she meets one or more of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Nestor, MD | Center for Clinical and Cosmetic Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical and Cosmetic Research | Aventura | Florida | 33180 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39692702 | Derived | Nestor MS, Hetzel J, Awad N, Bhupalam V, Lu P, Molyneaux M. A Novel Injectable Polypeptide Nanoparticle Encapsulated siRNA Targeting TGF-beta1 and COX-2 for Localized Fat Reduction II: Phase I Clinical Trial. J Cosmet Dermatol. 2025 Feb;24(2):e16722. doi: 10.1111/jocd.16722. Epub 2024 Dec 18. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Dose-ranging, double-blind, vehicle-controlled
Not provided
Not provided
double-blind (investigator & subjects)
| Placebo Comparator |
1.0cc placebo |
|
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |