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

NCT05422378 | Completed Phase 1 FDA Drug

• 1 other identifier: SRN-705-010
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (7)

STP705, 120ug/mL, 0.5 cc

EXPERIMENTAL

Volume of Injection 0.5cc

Drug: STP705

STP705, 120ug/mL, 1.0 cc

EXPERIMENTAL

Volume of Injection 1.0cc

Drug: STP705

STP705, 240 ug/mL, 0.5 cc

EXPERIMENTAL

Volume of Injection 0.5cc

Drug: STP705

STP705, 240ug/mL, 1.0 cc

EXPERIMENTAL

Volume of Injection 1.0cc

Drug: STP705

STP705, 320ug/mL, 0.5 cc

EXPERIMENTAL

Volume of Injection 0.5cc

Drug: STP705

STP705, 320ug/mL, 1.0 cc

EXPERIMENTAL

Volume of Injection 1.0cc

Drug: STP705

Vehicle

PLACEBO COMPARATOR

1.0cc placebo

Drug: STP705

Interventions

STP705 DRUG

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

Also known as: STP705 Powder for Injection

STP705, 120ug/mL, 0.5 cc; STP705, 120ug/mL, 1.0 cc; STP705, 240 ug/mL, 0.5 cc; STP705, 240ug/mL, 1.0 cc; STP705, 320ug/mL, 0.5 cc; STP705, 320ug/mL, 1.0 cc; Vehicle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To enter the study, a subject must meet the following criteria:
• Subject is a male or non-pregnant female 18-65 years of age.
• Subject has provided written informed consent.
• 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.
• 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.

You may not qualify if:

• A subject is ineligible to enter the study if he/she meets one or more of the following criteria:
• Subject is pregnant, lactating, or is planning to become pregnant during the study.
• Subject has a significant active systemic or localized abdominal infection.
• Subject has a body mass index (BMI) ≥40.
• Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
• 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.
• Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., HIV positive, malignancy), medication use, or other factors.
• 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.
• 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.
• Subject is currently enrolled in an investigational drug, biologic, or device study.
• Subject has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to first injection of the test article.
• Subject has a history of sensitivity to any of the ingredients in the test articles (see Section 6.1).
• 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.

Sponsors & Collaborators

• Sirnaomics: lead

Study Sites (1)

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Publications (1)

• 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.

  PMID: 39692702 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Injections

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Nestor, MD

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind (investigator \& subjects)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose-ranging, double-blind, vehicle-controlled

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 16, 2022
• Study Start: August 1, 2022
• Primary Completion: February 3, 2023
• Study Completion: June 27, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

US (1)