NCT04106050

Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

A Phase 1b, Randomized, Double-Blind, Parallel, Placebo- and Active-Controlled, Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers
• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	BIIB095	Administered as specified in the treatment arm.
DRUG	BIIB074	Administered as specified in the treatment arm.
DRUG	Placebo	Administered as specified in the treatment arm.
DRUG	Lidocaine	Administered as specified in the treatment arm.

Timeline

• Start date: 2020-09-30
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2019-09-26
• Last updated: 2021-03-22