NCT07369076
A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.
Recruiting · Phase 1, Phase 2 · Nura Bio · registry updated 2026-09-17
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The purpose of this trial is to learn about the effects of NB-4746 compared with placebo in people with amyotrophic lateral sclerosis. The questions this trial aims to answer in comparing NB-4746 to placebo are: * What adverse events associated with taking NB-4746 are reported during this trial? (An adverse event is any sign or symptom that participants have during a trial. Adverse events may or may not be caused by treatments in the trial.) * How does NB-4746 move into, through, and out of the body of the participants? * What is the change in the level of neurofilament light (NfL) in the participants' blood? (NfL is a marker used to measure the extent of damage to the nerve cells.) This trial has 2 parts. The trial doctors will start Part A before starting Part B of the trial. Participants have an option to enter the open label extension after completing Part A or Part B. Part A: Participants will be randomly placed into 1 of the 3 groups. There are equal chances to be assigned to either group. Group 1: Participants will receive NB-4746 capsules at a low dose to take by mouth twice daily for 1 month....
Inclusion
- \- ALS Criteria for Phase 1b:
- Participants in Phase 1b must have:
- Diagnosis of ALS per Gold Coast Criteria; and
- Symptom onset ≤48 months prior to randomization on Day 1. Date of first ALS symptom (any ALS symptom) onset is defined as the onset of weakness in the limbs, bulbar region, or trunk. Weakness in the bulbar region includes dysarthria and dysphagia.
- ALS Criteria for Phase 2:
- Participants in Phase 2 must have:
Exclusion
- Presence of tracheostomy or permanent assisted ventilation; defined as \> 22 hours daily of mechanical ventilation for more than 1 week (7 days).
- History or presence of clinically significant uncontrolled medical conditions (other than ALS) that include cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs; or interfering with the interpretation of data as determined by the Investigator.
- Lifetime history of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Fully resected basal cell carcinoma and squamous cell carcinoma with no evidence of recurrence for 1 year are permitted.
- Female participants who have a positive serum pregnancy test at Screening, positive urine pregnancy test on Day 1, or who are breastfeeding on Day 1.
- Has a spinal deformity or other condition that may prevent the performance of a lumbar puncture.
- International Normalized Ratio (INR) \>1.4, platelet count \<50,000/μL, or use of warfarin, heparin, or direct oral anticoagulants.