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Trial record 1 of 1 for:    NCT05422378
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A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05422378
Recruitment Status : Completed
First Posted : June 16, 2022
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Sirnaomics

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 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
Actual Primary Completion Date : February 3, 2023
Actual Study Completion Date : June 27, 2023

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: STP705 Powder for Injection

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




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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05422378


Locations
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United States, Florida
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Sirnaomics
Investigators
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Principal Investigator: Mark Nestor, MD Center for Clinical and Cosmetic Research
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Responsible Party: Sirnaomics
ClinicalTrials.gov Identifier: NCT05422378    
Other Study ID Numbers: SRN-705-010
First Posted: June 16, 2022    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Abdominal
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight