RecruitingPhase 1Phase 2NCT07369076

A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.

A Phase 1b/2 Study to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.


Sponsor

Nura Bio

Enrollment

80 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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. Group 2: Participants will receive NB-4746 capsules at a high dose to take by mouth twice daily for 1 month. Group 3: Participants will receive placebo capsules to take twice daily for approximately 1 month. Part B: Participants will be randomly placed into 1 of the 2 groups. There are equal chances to be assigned to either group. Group 1: Participants will receive NB-4746 capsules at a dose determined by Part A to take by mouth twice daily for 12 weeks. Group 2: Participants will receive placebo capsules to take twice daily for approximately 12 weeks. None of the participants, trial doctors, or trial staff will know which treatment the participants will receive during Part A or B. Some trials are done this way because knowing what treatment the participants receive can affect the results of the trial. Doing a trial this way helps to make sure that the results are looked at with fairness across all treatments. Open-Label Extension: Upon the completion of Part A or Part B, the doctor will verify the participant's willingness to continue receiving study treatment. This open label extension continues until each participant completes up to 1 year of treatment. The trial doctors will check participants' ALS and general health throughout the trial.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called NB-4746 (Dose TBD), a drug called NB-4746 High dose, and others for people with amyotrophic lateral sclerosis(als). The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNB-4746 High dose

NB-4746 will be administered twice daily in 2 capsules (high dose)

DRUGNB-4746 Low dose

NB-4746 will be administered twice daily in 2 capsules (low dose)

DRUGPlacebo

Two capsules of placebo will be administered twice daily.

DRUGNB-4746 (Dose TBD)

Two capsules of NB-4746 will be administered twice daily (dose will be defined after Ph 1b data is reviewed).


Locations(8)

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Neuroscience Research Australia

Randwick, New South Wales, Australia

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Calvery Health care Bethlehem

Caulfield South, Victoria, Australia

Perron Institute

Nedlands, Western Australia, Australia

Stan Cassidy Center for Rehabilitation

Fredericton, New Brunswick, Canada

Genge Partners

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07369076


Related Trials