A Botanical Drug Extracted From Antrodia cinnamomea: A First-in-human Phase I Study in Healthy Volunteers

Authors: Yu-Tso Liao, Kai-Wen Huang, Wan-Jing Chen, and Tzung-Hsien Lai

Journal: Journal of the American College of Nutrition

Study Design: Open-label, single-arm, dose-escalation study

Participants: 18 healthy volunteers

Intervention: LEAC-102, a botanical drug extracted from Antrodia cinnamomea, administered at doses of 597.6, 1195.2, 1792.8, 2390.4, or 2988 mg/day for 1 month, plus 7 days of safety follow-up

Outcome Measures:

• Safety and tolerability
• Maximum tolerated dose (MTD)
• Dose-limiting toxicity (DLT)
• Clinical status
• Laboratory parameters (hematology, biochemistry, urinalysis)
• Adverse events
• Immunomodulatory effects (changes in immune cell populations and programmed cell death-1 (PD-1) expression)

Summary:

This first-in-human phase I study evaluated the safety, tolerability, and immunomodulatory effects of LEAC-102 in healthy volunteers. Participants received escalating doses of LEAC-102 for one month, followed by a 7-day safety follow-up. The study found that LEAC-102 was well-tolerated at all doses, with no serious adverse events reported. The MTD was determined to be 2988 mg/day based on one participant experiencing urticaria. Additionally, LEAC-102 showed potential immunomodulatory effects by increasing NK, NKT, and dendritic cells in a dose-dependent manner, activating effector T cells, and upregulating PD-1 expression. The study concluded that LEAC-102 is safe and well-tolerated in healthy adults and exhibits potential immunomodulatory functions.   Sources and related content