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

What Was Tested

The trial (phase 1) is built around Glutathione for multiple sclerosis.

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).

It had nine arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 47 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg. Able to participate and willing to give written informed consent and to comply with the study restrictions. Age: 18 to 65 years, both men and women. Patients with Relapsing Remitting Multiple Sclerosis (RRMS). Patients with Secondary Progressive Multiple Sclerosis (SPMS) and.

The full record lists 9 inclusion and 34 exclusion criteria; among the exclusions: positive hepatitis b surface antigen (hbsag), hepatitis c antibody (hcv ab), or human immunodeficiency virus antibody (hiv ab) at screening; use of cyp3a4-inhibiting drugs, including quinine containing drinks (bitter lemon and tonic water) is prohibited within 21 days of study drug administration; subject has used grapefruit, grapefruit juice, grapefruit-containing products, seville oranges, or pomelo-containing products, within 14 days prior to day -1.

How the Study Was Run

The set-up was an interventional.

It started in 2013-11 with completion listed for 2015-01.

It ran at 2 sites in Netherlands (2).

What Was Measured

Primary outcome: Number of subjects with adverse events as a measure of safety and tolerability of 2B3-201 (time frame: 3 weeks).

It also tracked 6 secondary outcomes, for example Measure changes in central nervous system (CNS) functioning after intravenous administration of 2B3-201 by using the Neurocart test battery.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Glutathione in 47 people with multiple sclerosis.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, Multiple sclerosis research.