Safety, Tolerability, and Pharmacokinetics of FHND1002 Granules in Healthy Adults
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Peak Plasma Concentration (Cmax) — 4 weeks
This outcome measures the maximum observed plasma concentration of FHND1002 and its metabolites after single and multiple doses. - Time to Peak Plasma Concentration (Tmax) — 4 weeks
This outcome evaluates the time required to reach maximum plasma concentration of FHND1002 and its metabolites. - Area Under the Curve from 0 to the Last Quantifiable Time Point (AUClast) — 4 weeks
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. - Area Under the Curve Over the Dosing Interval (AUCτ) — 4 weeks
This outcome evaluates drug exposure during the dosing interval at steady state. τ means the dosing intervals. - Trough Concentration (Cmin) — 4 weeks
The parameter is for multiple dose study. This outcome measures the minimum plasma concentration of FHND1002 and its metabolites before the next dose. - Average Plasma Concentration (Cavg) — 4 weeks
The parameter is for multiple dose study. This outcome evaluates the average plasma concentration of FHND1002 during the dosing interval at steady state. - Accumulation Ratio (Rac) — 4 weeks
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). - Elimination Half-life (t1/2) — 4 weeks
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. - Area Under the Curve from 0 to Infinity (AUC0-inf) — 4 weeks
This outcome evaluates the total drug exposure from the time of dosing extrapolated to infinity for FHND1002 and its metabolites. - Incidence of Adverse Events(AEs) — 7 weeks
This endpoint evaluates the safety of FHND1002 by monitoring the incidence of adverse events (AEs) - Incidence of Adverse Drug Reactions (ADRs) — 7 weeks
This endpoint evaluates the safety of FHND1002 by monitoring the incidence of adverse drug reactions (ADRs),
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The first hospital of Lanzhou University | Lanzhou | Gansu |
More Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06782958 on ClinicalTrials.gov ↗ ← All trials in China