Clinical trial NCT05422378: A Study to Evaluate Safety, Tolerability of Subcutaneous Injection in Adult Subjects Undergoing Abdominoplasty
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of Subcutaneous Injection of STP705 in Adult Subjects Undergoing Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Abdominal Obesity
Lead sponsor: Sirnaomics
Sponsor class: INDUSTRY
First posted: 2022-06-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dose-ranging, double-blind, vehicle-controlled
Primary purpose: TREATMENT

Brief summary: Dose-ranging, randomized, double-blind, vehicle-controlled study

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.

Eligibility 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.

Primary outcomes:
measure: Number of subjects with presence and severity of the following Local Skin Reactions (LSR): erythema, edema, bruising.
timeFrame: 24 weeks
measure: Number of subjects with presence and severity of the following Local Skin Reactions (LSR): pain and stinging/burning.
timeFrame: 24 weeks
measure: Incidence (severity and causality) of any AEs
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
Study officials:
affiliation: Center for Clinical and Cosmetic Research
name: Mark Nestor, MD
role: PRINCIPAL_INVESTIGATOR
References: