Phase 1 Clinical Trial for Dental Caries Product Successfully Completed

Posted on October 9, 2013

 

LOS ANGELES, Aug. 22, 2013 (GLOBE NEWSWIRE) -- C3 Jian, Inc., a Los Angeles based private biotechnology company focused on providing improved oral healthcare, announced the successful completion of a Phase 1 clinical trial related to its novel peptide therapeutic product referred to as C16G2. C3 Jian is developing C16G2 for the prevention of dental caries (tooth decay).

The Phase 1 clinical trial was a randomized, double-blind, placebo-controlled study that included a dose escalation period. The trial focused on evaluating safety and pharmacokinetics, along with initial microbiology of C16G2 administered to healthy adults in a single oral dose of mouth rinse. A total of 36 subjects were enrolled in the study. No C16G2 related events, and no severe or serious adverse events were reported in the study.

The Phase 1 study was conducted at New York University's, Bluestone Center for Clinical Research. Mark Wolff, DDS, PhD, Professor and Chair of the Department of Cariology & Comprehensive Care at NYU College of Dentistry, served as the Principal Investigator.

"We are pleased to have completed our first IND clinical study. With the current C16G2 safety information and initial microbiology, both provided support to move into our Phase 2 Development Program, which we are eager to commence at the end of this year," said Laura A. Navalta, C3 Jian's Vice President of Clinical Operations.

The ultimate indication sought for C16G2 is prevention of dental caries in adults, adolescents and pediatrics. Dental caries, commonly known as tooth decay or "cavities," is rated the most common chronic childhood disease according to the U.S. Surgeon General. In the U.S. alone, over $100 billion is spent annually on oral health expenditures and a majority of these expenses is directly related to dental caries.

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