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

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.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

200mg FHND1002(postprandial)

Participants will receive a one-time dose (200 mg) under postprandial conditions

Sponsors & Collaborators

• Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Ting Wang · LanZhou University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-05

Primary Completion

2025-03-03

Completion

2025-06-05

Countries

• China

Study Locations