A Study of IPL344 in the Treatment of ALS Patients

Inclusion Criteria

• •1. Male or female participants ages ≥18 to 80 years
• •2. Consenting participants fulfilling the El Escorial criteria for probable and definite ALS (sporadic and familial)
• •3. Participant has ALSFRS-R score \>20, the latest ALSFRS-R test should be no more than 6 weeks before screening visit, AND:
• •1. a disease progression rate greater than 0.55 ALSFRS-R point per month on average, over at least 4 months, prior to the latest ALSFRS-R test OR
• •2. a decline of at least 3 points in ALSFRS-R score within the last 4 months prior to the latest ALSFRS-R test
• •4. Previous data of Force Vital Capacity (FVC) of ≥60% at least 3 months before screening and not more than 12 months.
• •5. Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed.
• •6. BMI 18.5 to 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
• •7. If taking riluzole or edaravone, the participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit.
• •8. Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry.
• •9. Medically is able and willing to undergo placement and maintain a central venous catheter as determined by the investigator.
• •10. Participant has a competent caregiver or qualified individual who can and will be responsible for the administration of study drug and reporting home activities.
• •11. Geographic accessibility to the study site
• •12. Females must not be lactating or pregnant at Screening, as documented by a negative beta-human chorionic gonadotropin \[ß-hCG\] (or human chorionic gonadotropin \[hCG\].
• •13. Women of child-bearing potential or males whose partners are women of child-bearing potential use an effective method of contraception throughout the trial.