Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group, Adaptive Proof-of-concept, Dose-selecting Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intranasal Cenegermin (recombinant human Nerve Growth Factor [rhNGF]) in Adult Participants with subacute moderate to severe Traumatic Brain Injury (TBI).

Trial status: Authorised 1. Sliding and good outcome in Glasgow Outcome Scale – Extended at month 6., 2. Through 12 months following the first administration of investigational product., 3. Incidence of treatment-emergent serious and non-serious adverse events, and adverse events of special interest., 4. Participant incidence of study discontinuation for tolerability reasons., 5. Change from baseline on vital signs, 12-lead ECG results, clinical laboratory assessments, physical examinations, brain MRI, C-SSRS and blood levels of ADA. 1. Incidence of treatment-emergent serious and non-serious adverse events through 6 months following the first intranasal administration of cenegermin.

1. Sliding and good outcome in Glasgow Outcome Scale – Extended at month 6., 2. Through 12 months following the first administration of investigational product., 3. Incidence of treatment-emergent serious and non-serious adverse events, and adverse events of special interest., 4. Participant incidence of study discontinuation for tolerability reasons., 5. Change from baseline on vital signs, 12-lead ECG results, clinical laboratory assessments, physical examinations, brain MRI, C-SSRS and blood levels of ADA.

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 146 participants