Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095. Part B (optional): Equivalent objectives are pursued for BIIB074.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Change in Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Compound Muscle Action Potential Threshold Tracking (CMAP-TT) in the Median Nerve of Healthy Participants
Time frame: Baseline (Day 1), Day 8
Change in Sensory Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Sensory Nerve Action Potential Threshold Tracking (SNAP-TT) in the Median Nerve of Healthy Participants
Time frame: Baseline (Day 1), Day 8
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22
Area Under the Curve from Time Zero to Time of the Last Measurable Concentration (AUClast)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Area Under the Curve within a Dosing Interval (AUCtau)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Maximum Observed Concentration (Cmax)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Trough Concentration (Ctrough)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Time to Reach Maximum Observed Concentration (Tmax)
Time frame: Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
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Administered as specified in the treatment arm.