Safety, Tolerability, and Pharmacokinetics of FHND1002 Granules in Healthy Adults

The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of FHND1002 granules in healthy adult volunteers. The study will also assess how a high-fat meal affects the PK characteristics of FHND1002. The main questions this study aims to answer are: What are the safety and tolerability of FHND1002 granules when administered as single or multiple doses? What are the PK parameters of FHND1002, and what metabolites can be identified in humans? Participants will: Take FHND1002 granules or a placebo once daily, either as a single dose or for 7 consecutive days. Attend regular clinic visits for checkups, tests, and blood sample collection. Undergo assessments, including monitoring for adverse events, physical exams, vital signs, ECGs, and laboratory tests.

NCT Number	NCT06782958
Lead Sponsor	Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Conditions	Amyotrophic Lateral Sclerosis (ALS)
Enrollment	72 participants
Start Date	2024-07-05
Primary Completion	2025-03-03 (estimated)
Study Completion	2025-06-05 (estimated)
Updated on ClinicalTrials.gov	2025-01-20