RJV001 Study in Adults Receiving Abdominoplasty
Condition: Submental Fat (SMF); Double Chin
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): RJV001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment