ProteLight Pharma Completes First Human Dosing of Antimicrobial Peptide PL-3301 Oral Gel in Phase I Clinical Trial
2025-10-16
Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd. ("ProteLight Pharma") announced on October 16, 2025, the completion of the first participant enrollment and dosing in the Phase I clinical trial for its first-in-class drug, Antimicrobial Peptide PL-3301 Oral Gel, with safety follow-up for the participants currently ongoing.
This study is a single-dose, dose-escalation trial conducted in healthy adult participants. It aims to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of PL-3301 Oral Gel, thereby providing a foundation for subsequent clinical development. The study has already received approval from the National Medical Products Administration (NMPA), and clinical research activities are currently progressing actively.
About Antimicrobial Peptide PL-3301 Oral Gel
As a novel, broad-spectrum anti-infective polypeptide drug independently developed by ProteLight Pharma with complete intellectual property rights, Antimicrobial Peptide PL-3301 Oral Gel is a first-in-class, non-antibiotic anti-infective agent. It possesses unique mechanisms of action against both fungi and bacteria. Preclinical data supported its advancement into clinical development, with the aim of providing a new therapeutic option for the treatment of oropharyngeal candidiasis.
About Oropharyngeal Candidiasis
Oropharyngeal candidiasis is an oral mucosal infection primarily caused by Candida albicans, characterized by symptoms such as oral white patches and a burning sensation. It commonly occurs in individuals with compromised immunity, including the very young or elderly, those with conditions like HIV/AIDS, cancer patients undergoing therapy, and users of certain medications like systemic steroids or long-term antibiotics [1]. Globally, it affects approximately 10% of adults, with a potentially higher prevalence in developing countries [2].
References
Taylor M, Brizuela M, Raja A (2023). Oral Candidiasis. Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; Jan.
Chinese Expert Consensus on the Multidisciplinary Decision-Model for Oral Candidiasis (Thrush) (2025 Edition).
