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

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 5, 2024

Primary Completion Date

March 3, 2025

Study Completion Date

June 5, 2025

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

Trial Locations (1)

730013

The first hospital of Lanzhou University, Lanzhou

All Listed Sponsors
lead

Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.

INDUSTRY