NCT02048358

Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients

Randomized, Double-blind, Placebo- and Active Comparator- Controlled Crossover Study in Healthy Male Subjects and an Open Label Study in Healthy Subjects and MS Patients to Assess the Safety, Pharmacokinetics and Pharmacodynamics of 2B3-201

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: BBB-Therapeutics B.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

In this first in human study the aim is to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201 in a randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in 18 healthy male subjects (part 1). Furthermore, the findings obtained from part 1 will be extended and confirmed in a subsequent parallel open label study in 18 healthy male and 12 MS patients and an open label study with methylprednisolone as comparator in 12 female volunteers (part 2).

Conditions

• Healthy Volunteers
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	2B3-201
DRUG	Placebo
DRUG	Methylprednisolone hemisuccinate

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2014-01-29
• Last updated: 2015-02-06

Locations

2 sites across 1 country: Netherlands