Oral BPC-157 (PCO-02) Phase 1 Trial Completed, Assessing Safety and Pharmacokinetics in Healthy Adults

Body-protective compound (BPC) 157 is a synthetic pentadecapeptide derived from human gastric juice, known for its broad cytoprotective and regenerative properties across various organ systems. It has demonstrated efficacy in preclinical models for wound healing, gastrointestinal integrity, and tissue repair, including muscle, tendon, and bone. Despite extensive preclinical data, human clinical data, particularly regarding safety and pharmacokinetics of orally administered forms, has been scarce. This Phase 1 trial aimed to bridge this gap, providing foundational data for future clinical development of BPC-157.

This was a single-center, Phase 1 pilot study conducted at Hospital Angeles, Tijuana, involving healthy male and female volunteers aged 18 to 35 years. The intervention involved oral administration of PCO-02 tablets, each containing 1 mg of BPC-157, or placebo. The study comprised two phases: Phase 1a involved a single dose administration of 1, 3, or 6 tablets of PCO-02 or placebo. Phase 1b involved oral administration of 3 tablets of PCO-02 or placebo, three times daily for 2 weeks. The primary endpoints were to assess the safety and pharmacokinetics of orally administered BPC-157.