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.
This study aims to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of FHND1002 granules in healthy adult volunteers. The study is divided into two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase, with an additional evaluation of the effect of a high-fat meal on the PK characteristics of FHND1002. The primary objectives of this study are: To assess the safety and tolerability of FHND1002 granules following single and multiple doses in healthy volunteers. To evaluate the impact of a high-fat meal on the PK profile of FHND1002 granules after a single oral dose. The secondary objectives include: To characterize the pharmacokinetic parameters of FHND1002 granules in healthy volunteers. To identify and conduct preliminary research on drug metabolites in humans. This single-center, randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase I clinical trial involves healthy adult volunteers. Based on preclinical pharmacodynamic, pharmacokinetic, and toxicological studies, as well as the formulation specifications of FHND1002 (25 mg and 100 mg), the maximum recommended starting dose for humans is set at 50 mg. In the SAD phase, five dose groups (50 mg, 100 mg, 150 mg, 200 mg, and 250 mg) will be included, with 8 participants in each group (6 receiving FHND1002 and 2 receiving a placebo). Additionally, a food effect cohort (100 mg) will include 16 participants (14 receiving FHND1002 and 2 receiving a placebo), split into two groups to evaluate the impact of food under fasting and postprandial conditions. In the MAD phase, three dose groups (100 mg, 150 mg, and 200 mg) will be included, with 8 participants per group (6 receiving FHND1002 and 2 receiving a placebo). Participants will receive FHND1002 or placebo once daily under fasting conditions for 7 consecutive days. Throughout the study, participants will undergo regular assessments, including blood sample collection for PK analysis, adverse event (AE) monitoring, and evaluations such as physical exams, vital signs, ECGs, and laboratory tests. This study is expected to provide important data on the safety, tolerability, and pharmacokinetics of FHND1002, contributing to its further clinical development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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.
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.
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.
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.
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.
Participants will receive a one-time dose (200 mg) under postprandial conditions
The first hospital of Lanzhou University
Lanzhou, Gansu, China
Peak Plasma Concentration (Cmax)
This outcome measures the maximum observed plasma concentration of FHND1002 and its metabolites after single and multiple doses.
Time frame: 4 weeks
Time to Peak Plasma Concentration (Tmax)
This outcome evaluates the time required to reach maximum plasma concentration of FHND1002 and its metabolites.
Time frame: 4 weeks
Area Under the Curve from 0 to the Last Quantifiable Time Point (AUClast)
AUClast means Area Under the Concentration-Time Curve from 0 to the Last Quantifiable Time Point . This outcome assesses the total drug exposure up to the last measurable plasma concentration after single and multiple doses of FHND1002.
Time frame: 4 weeks
Area Under the Curve Over the Dosing Interval (AUCτ)
This outcome evaluates drug exposure during the dosing interval at steady state. τ means the dosing intervals.
Time frame: 4 weeks
Trough Concentration (Cmin)
The parameter is for multiple dose study. This outcome measures the minimum plasma concentration of FHND1002 and its metabolites before the next dose.
Time frame: 4 weeks
Average Plasma Concentration (Cavg)
The parameter is for multiple dose study. This outcome evaluates the average plasma concentration of FHND1002 during the dosing interval at steady state.
Time frame: 4 weeks
Accumulation Ratio (Rac)
Accumulation Ratio (Rac) is for Cmax and AUCτ. The outcome evaluates the accumulation of FHND1002 after multiple doses, calculated as the ratio of steady-state to single-dose parameters (e.g., Rac\_Cmax, Rac\_AUCτ).
Time frame: 4 weeks
Elimination Half-life (t1/2)
Elimination Half-life (t1/2) of FHND1002 assesses the time required for the plasma concentration of FHND1002 to decrease by half during the elimination phase.
Time frame: 4 weeks
Area Under the Curve from 0 to Infinity (AUC0-inf)
This outcome evaluates the total drug exposure from the time of dosing extrapolated to infinity for FHND1002 and its metabolites.
Time frame: 4 weeks
Incidence of Adverse Events(AEs)
This endpoint evaluates the safety of FHND1002 by monitoring the incidence of adverse events (AEs)
Time frame: 7 weeks
Incidence of Adverse Drug Reactions (ADRs)
This endpoint evaluates the safety of FHND1002 by monitoring the incidence of adverse drug reactions (ADRs),
Time frame: 7 weeks
Coefficient of Variation (DF) of Pharmacokinetic Parameter
This outcome assesses the variability in pharmacokinetic parameters such as Cmax and AUCτ to understand inter- and intra-subject variability.
Time frame: 4 weeks
Apparent Clearance (CL/F)
This outcome evaluates the rate of drug clearance from the plasma after oral administration of FHND1002.
Time frame: 4 weeks
Apparent Volume of Distribution (Vz/F)
This outcome assesses the apparent volume of distribution of FHND1002 following oral administration, providing an estimate of drug distribution in the body.
Time frame: 4 weeks
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