A Phase 1 interventional study of RJV001 and Placebo in Submental Fat (SMF) and Double Chin, sponsored by Rejuven Dermaceutical Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by Rejuven Dermaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
In this study, we are testing a new drug against submental fat (SMF), which is characterized with the accumulation of fat under the chin that often appears as a "double chin". The 2018 American Society for Dermatologic Surgery Consumer Survey on Cosmetic Dermatologic Procedures indicated that 73% of respondents were bothered by "excess fat under the chin/neck". This condition of loose or sagging skin under the chin may affect facial symmetry and attractiveness, which can lead to social embarrassment and a negative self-image in many patients.
There is an insufficiency in effective drugs against SMF and double chin. Although an injectable small molecule can be used for improvement of double chin, but its side effects are evident and its cost is high. As such, there remains a real need to develop a cost-effective method to improve appearance of SMF and double chin.
The therapies directed against adipocytes represent a novel therapeutical approach for improving the appearance of double chin. Furthermore, these treatments would optimally work by novel mechanisms so that the enhanced adverse effects at injection sites will not limit their use. Our studies suggest that RJV001 may fulfill these requirements.
Adipocytes are attached to an extracellular matrix (ECM) that mainly consists of a collagen network, the degradation of which may induce apoptosis of adipocytes, leading to the improvement of the double chin's appearance. Collagenases are enzymes that break the peptide bonds in collagen; collagenase-induced destruction of the collagen network may lead to improvement in the appearance of the double chin.
Rejuven is currently developing RJV001 for improving the appearance of moderate to severe convexity or fullness-associated SMF in adults. RJV001 is a mutant recombinant collagenase of Clostridium histolyticum, which contains one amino acid difference. This amino acid is in the active center and preclinical studies showed that Kcat of RJV001 was significantly lower than that of the wild type enzyme, but Km of RJV001 was close to that of the wild type. Preclinical studies conducted by Rejuven also demonstrated that RJV001 can still effectively induce lipolysis of fat tissue and that the decreased bioactivity may have the benefit of decreased adverse effects.
This is the only study on the registry with Rejuven Dermaceutical Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dosage group A will consist of 6 subjects, 1:1:1 (A1:A2:A3 below): A1: 0.04 mg/injection; A2: 0.075 mg/injection; A3: 0.15 mg/injection Two subjects will be dosed in the area scheduled for resection with 5 injections of the lowest of the 3 RJV001 test article strengths (i.e., 0.04 mg/injection); the two subjects will also be dosed with a single injection of vehicle in the area scheduled for resection for a total of 6 injections. At the conclusion of a given test article dose group, if tolerated, enrollment will continue to the next higher dose after approval to advance based upon an interim safety review. This same process will be repeated for the 0.075 mg/injection dose with 2 additional subjects. Assuming the interim safety review for the mid dose (i.e., 0.075 mg/injection) is deemed acceptable, the 2 final subjects will be treated with the high dose (0.15 mg/injection).
Drug: RJV001 · Drug: Placebo
Dosage group B will consist of 3 subjects (if only 1 dose from Dosage group A is well tolerated) or 6 subjects (if 2 doses from Dosage group A are well tolerated), randomized 1:1 (B1:B2 below). B1: RJV001 Solution for Injection, Dose 1 B2: RJV001 Solution for Injection, Dose 2 Subjects will be dosed with 1 RJV001 test article (i.e., one of the 2 highest concentrations of RJV001 doses that were well tolerated in Dosage group A, referred to as Dose 1 and Dose 2). Up to 13 injections (12 active and 1 vehicle) will be administered in an open label manner in the area scheduled for resection. If tolerated, enrollment will continue to Dosage group C after approval to advance based upon an interim safety review.
Drug: RJV001 · Drug: Placebo
Dosage group C will consist of 3 subjects (if only 1 dose from dosage group B is well tolerated) or 6 subjects (if 2 doses from Dosage group B are well tolerated), randomized 1:1 (C1:C2 below). * C1: RJV001 Solution for Injection, Dose 1 * C2: RJV001 Solution for Injection, Dose 2 Subjects will be dosed with 1 RJV001 test article (i.e., one of the 2 highest concentrations of RJV001 doses that were well tolerated in Cohort B, referred to as Dose 1 and Dose 2). Up to 31 injections (30 active and 1 vehicle) will be administered in an open-label manner in the area scheduled for resection.
Drug: RJV001 · Drug: Placebo
Subcutaneous injection in the abdomen
The placebo formulation has the same shape, color, and qualitative composition as the RJV001 freeze dried powder, with the exception that RJV001 drug substance has been removed. For each cohort group, a placebo will be injected in a single site in the same area as the treatment.
Local and systemic adverse events following administration of RJV001
* Necrosis * Thrombosis * Ischemia * Gangrene * Injection site discoloration * Allergic dermatitis * Neovascularization * Nerve injury * Pain
Time frame: 30 minutes
Plan to share: No
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