Status:
NOT_YET_RECRUITING
FHND1002 for ALS Treatment: Phase 2
Lead Sponsor:
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II clinical trial evaluating the effectiveness and safety of an investigational drug, FHND1002 granules, in adults with Amyotrophic Lateral Sclerosis (ALS). The main goals are: To de...
Eligibility Criteria
Inclusion
- Subjects must be ≥18 years of age at the time of signing the informed consent form.
- Subjects must have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) meeting the revised El Escorial World Federation of Neurology criteria categories including Clinically Definite ALS, Clinically Probable ALS, Laboratory-supported Probable ALS, or Clinically Possible ALS.
- Subjects must demonstrate a documented mean monthly decline of ≥0.5 points in the ALS Functional Rating Scale-Revised (ALSFRS-R) score since initial diagnosis.
- During screening, subjects must exhibit a percent predicted forced vital capacity (FVC%) ≥70%; note that use of non-invasive ventilation (NIV) is exclusionary.
- Disease duration must be ≤2 years calculated from the onset of the first ALS-related symptom.
- At screening, subjects must have an ALSFRS-R total score ≥30 with a swallowing function subscore ≥2 and all respiratory-related subscores at 4 points.
- Subjects must have a Body Mass Index (BMI) ≥18.5 kg/m².
- Subjects may or may not be receiving stable therapeutic doses of approved ALS medications (e.g., edaravone, riluzole) prior to enrollment, provided any existing regimen remains unchanged throughout the study.
- Subjects must demonstrate ability to understand study procedures, willingness to comply, voluntary participation, and provide signed informed consent.
Exclusion
- Subjects with coexisting neurological disorders that may mimic ALS symptoms or interfere with efficacy assessment (e.g., cervical/lumbar spondylosis, dementia, history of seizures except childhood febrile seizures) will be excluded.
- Subjects exhibiting motor conduction block or sensory nerve conduction abnormalities on electromyography (EMG) testing will be excluded.
- Subjects with any history of spinal surgery within 3 months prior to screening will be excluded.
- Subjects showing clinically significant laboratory abnormalities at screening including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 × upper limit of normal (ULN), or serum creatinine (Scr) \> ULN will be excluded.
- Subjects with severe/uncontrolled cardiac, hepatic, renal, hematologic, or neoplastic diseases, or active severe psychiatric disorders will be excluded.
- Exclusion applies to pregnant or lactating women, and subjects planning pregnancy during the study or within 3 months post-treatment; participants of childbearing potential unwilling to use highly effective contraception throughout the study and for 3 months after last dose are excluded.
- Subjects with known or suspected hypersensitivity to FHND1002 or its excipients will be excluded.
- Subjects who have participated in another investigational drug/device trial within 1 month prior to screening will be excluded.
- Subjects deemed by the Investigator to have any condition compromising safety, data integrity, or study compliance will be excluded.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07138014
Start Date
October 1 2025
End Date
March 1 2028
Last Update
August 22 2025
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