Phase 1/2RecruitingAge-related condition
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 (Industry)
- Enrolment
- 80 planned
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- NB-4746 High dose; NB-4746 Low dose; Placebo; NB-4746 (Dose TBD)
- Ages
- adults, older adults
- Registry
- NCT07369076
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Ph 1b - Number of TEAEs and SAEs
- Evaluate safety and tolerability of NB-4746 in adult participants with ALS.
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered