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Safety, Tolerability, and Pharmacokinetics of FHND1002 Granules in Healthy Adults
Sponsor: Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Summary
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.
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of FHND1002 Granules After Single and Multiple Doses in Healthy Adult Volunteers
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2024-07-05
Completion Date
2025-06-05
Last Updated
2025-01-20
Healthy Volunteers
Yes
Conditions
Interventions
50mg FHND1002
Participants will receive a daily oral dose of FHND1002 granules (50 mg) ,administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.
100mg FHND1002
Participants will receive a daily oral dose of FHND1002 granules (100 mg) , administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.
150 mg FHND1002
Participants will receive a daily oral dose of FHND1002 granules (150 mg), administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.
200 mg FHND1002(fasting)
Participants will receive a daily oral dose of FHND1002 granules (200 mg), administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.
250mg FHND1002
Participants will receive a daily oral dose of FHND1002 granules (250 mg), administered in the morning after fasting for at least 10 hours. The dose will be taken with 240 mL of water.
200mg FHND1002(postprandial)
Participants will receive a one-time dose (200 mg) under postprandial conditions
Locations (1)
The first hospital of Lanzhou University
Lanzhou, Gansu, China